THE DIAGNOSIS AND TREATMENT OF ACUTE ACHILLES TENDON RUPTURE
Transcription
THE DIAGNOSIS AND TREATMENT OF ACUTE ACHILLES TENDON RUPTURE
THE DIAGNOSIS AND TREATMENT OF ACUTE ACHILLES TENDON RUPTURE GUIDELINE AND EVIDENCE REPORT Adopted by the American Academy of Orthopaedic Surgeons Board of Directors December 4, 2009 Disclaimer This Clinical Practice Guideline was developed by an AAOS physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances. Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to Clinical Practice Guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to voting on the recommendations contained within this Clinical Practice Guidelines. Funding Source This Clinical Practice Guideline was funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document. FDA Clearance Some drugs or medical devices referenced or described in this Clinical Practice Guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice. Copyright All rights reserved. No part of this Clinical Practice Guideline may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the AAOS. Published 2009 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018 First Edition Copyright 2007 by the American Academy of Orthopaedic Surgeons ii Summary of Recommendations The following is a summary of the recommendations in the AAOS’ clinical practice guideline, The Diagnosis and Treatment of Acute Achilles Tendon Rupture. The scope of this guideline is specifically limited to acute Achilles tendon rupture. This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly urged to consult the full guideline and evidence report for this information. We are confident that those who read the full guideline and evidence report will also see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility. This summary of recommendations is not intended to stand alone. Treatment decisions should be made in light of all circumstances presented by the patient. Treatments and procedures applicable to the individual patient rely on mutual communication between patient, physician and other healthcare practitioners. 1. In the absence of the reliable evidence, it is the opinion of this work group that a detailed history and physical exam be performed. The physical examination should include two or more of the following tests to establish the diagnosis of acute Achilles tendon rupture: o o o o Clinical Thompson test (Simmonds squeeze test) Decreased ankle plantar flexion strength Presence of a palpable gap (defect, loss of contour) Increased passive ankle dorsiflexion with gentle manipulation Strength of Recommendation – Consensus* Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. iii 2. We are unable to recommend for or against the routine use of magnetic resonance imaging (MRI), ultrasound (ultrasonography), and radiograph (roentgengrams, xrays) to confirm the diagnosis of acute Achilles tendon rupture. Strength of Recommendation – Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. 3. Non-operative treatment is an option for all patients with acute Achilles tendon rupture. Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. 4. For patients treated non-operatively, we are unable to recommend for or against the use of immediate functional bracing for patients with acute Achilles tendon rupture. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. iv 5. Operative treatment is an option in patients with acute Achilles tendon rupture. Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. 6. In the absence of reliable evidence, it is the opinion of the work group that although operative treatment is an option, it should be approached more cautiously in patients with diabetes, neuropathy, immunocompromised states, age above 65, tobacco use, sedentary lifestyle, obesity (BMI >30), peripheral vascular disease or local/systemic dermatologic disorders. Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. 7. For patients who will be treated operatively for an acute Achilles tendon rupture, we are unable to recommend for or against preoperative immobilization or restricted weight bearing. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. v 8. Open, limited open and percutaneous techniques are options for treating patients with acute Achilles tendon rupture. Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. 9. We cannot recommend for or against the use of allograft, autograft, xenograft, synthetic tissue, or biologic adjuncts in all acute Achilles tendon ruptures that are treated operatively. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. 10. We cannot recommend for or against the use of antithrombotic treatment for patients with acute Achilles tendon ruptures. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. vi 11. We suggest early (≤ 2 weeks) post-operative protected weight bearing for patients with acute Achilles tendon rupture who have been treated operatively Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. 12. We suggest the use of a protective device that allows mobilization by 2- 4 weeks post operatively. Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. 13. We are unable to recommend for or against post-operative physiotherapy for patients with acute Achilles tendon rupture Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. vii 14. In all patients with acute Achilles tendon rupture, irrespective of treatment type, we are unable to recommend a specific time at which patients can return to activities of daily living. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. 15. In patients who participate in sports it is an option to return them to sports within 3-6 months after operative treatment for acute Achilles tendon rupture. Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. 16. In patients with acute Achilles tendon rupture treated non-operatively, we are unable to recommend a specific time at which patients can return to athletic activity. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. viii * While we strongly encourage reviewers to read the full guideline, please refer to the sections titled “Judging the Quality of Evidence” and “Defining the Strength of the Recommendations Table 1” for a detailed description of the link between the evidence supporting the Strength of a Recommendation and the language of the guideline. ix Work Group Christopher P Chiodo MD, Chair Brigham Orthopedic Associates 75 Francis Street Boston MA 02115 Guidelines and Technology Oversight Chair: William C. Watters, III, MD 6624 Fannin #2600 Houston, TX 77030 Mark Glazebrook MD, Vice-Chair Queen Elizabeth Health Sciences Center Halifax Infirmary Suite 4867 1796 Summer Street Halifax NS B3H 3A7 Canada Guidelines and Technology Oversight ViceChair: Michael J. Goldberg, MD Department of Orthopaedics Seattle Children’s Hospital 4800 Sand Point Way NE Seattle, WA 98105 Eric Michael Bluman MD PhD Madigan Army Medical Center ATTN: MCHJ-SOP (Ortho Clinic) 9040 A Reid Street Tacoma WA 98431-1100 Evidence Based Practice Committee Chair: Michael Keith, MD 2500 Metro Health Drive Cleveland, OH 44109-1900 Bruce E Cohen MD 1783 Sterling Road Charlotte NC 28209 AAOS Staff: Robert H. Haralson III, MD, MBA AAOS Medical Director 6300 N River Road Rosemont, IL 60018 John E Femino MD Department of Orthopedics University of Iowa Hospital and Clinics JPP 01022 200 Hawkins Drive Iowa City IA 52242 Charles M. Turkelson, PhD Director of Research and Scientific Affairs Eric Giza MD UC Davis Dept of Orthopaedics Ambulatory Care Services Bldg 4860 Y St #3800 Sacramento, CA 95817 Janet L. Wies MPH AAOS Clinical Practice Guideline Mgr AAOS Research Analysts Laura Raymond MA - Lead Analyst Sara Anderson MPH – Lead Analyst Kevin Boyer BS Patrick Sluka MPH x Peer Review Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization or the individuals listed below nor does it is any way imply the reviewer supports this document. The following organizations participated in peer review of this clinical practice guideline and gave explicit consent to be listed as a peer review organization of this document: American Academy of Family Practitioners American Academy of Physical Medicine and Rehabilitation American College of Foot and Ankle Surgeons American Orthopaedic Foot and Ankle Society American Orthopaedic Society for Sports Medicine American Physical Therapy Association American Podiatric Medical Association Individuals who participated in the peer review of this document and gave their explicit consent to be listed as reviewers of this document are: Avrill Roy Berkman, MD Christopher R. Carcia, MD Michael Heggeness, MD Harvey Insler, MD John Kirkpatrick, MD Michael S. Lee, DPM, FACFA Angus McBryde Jr., MD Ariz R. Mehta, MD Lawrence Oloff, DPM Steven Raikin, MD Charles Reitman, MD John Richmond, MD Kevin Shea, MD Naomi Sheilds, MD Nelson F. Soohoo, MD Glenn Weinraub, DPM, FACFAS xi Table of Contents SUMMARY OF RECOMMENDATIONS .............................................................. III WORK GROUP ................................................................................................... X PEER REVIEW ................................................................................................... XI TABLE OF CONTENTS .................................................................................... XII LIST OF TABLES ............................................................................................. XVI I. INTRODUCTION ........................................................................................... 1 Overview........................................................................................................................................................ 1 Goals and Rationale ..................................................................................................................................... 1 Intended Users .............................................................................................................................................. 1 Patient Population ........................................................................................................................................ 2 Incidence ....................................................................................................................................................... 2 Burden of Disease ......................................................................................................................................... 2 Etiology .......................................................................................................................................................... 2 Risk Factors .................................................................................................................................................. 2 Emotional and Physical Impact of Achilles Tendon Rupture .................................................................. 2 Potential Benefits, Harms, and Contraindications .................................................................................... 2 II. METHODS ..................................................................................................... 3 Formulating Preliminary Recommendations ............................................................................................. 3 Study Inclusion Criteria ............................................................................................................................... 4 Outcomes Considered .................................................................................................................................. 4 Literature Searches ...................................................................................................................................... 5 Data Extraction............................................................................................................................................. 6 Judging the Quality of Evidence ................................................................................................................. 6 xii Defining the Strength of the Recommendations ........................................................................................ 7 Consensus Development ..............................................................................................................................10 Statistical Methods ......................................................................................................................................10 Peer Review ..................................................................................................................................................11 Public Commentary.....................................................................................................................................11 The AAOS Guideline Approval Process ....................................................................................................12 Revision Plans ..............................................................................................................................................12 Guideline Dissemination Plans ...................................................................................................................12 III. RECOMMENDATIONS AND SUPPORTING EVIDENCE ....................... 13 Recommendation 1 ......................................................................................................................................13 Summary of Evidence ...............................................................................................................................13 Excluded Articles......................................................................................................................................14 Study Quality ............................................................................................................................................15 Study Results ............................................................................................................................................16 Recommendation 2 ......................................................................................................................................17 Summary of Evidence ...............................................................................................................................18 Excluded Articles......................................................................................................................................18 Study Quality ............................................................................................................................................19 Study Results ............................................................................................................................................20 Recommendation 3 ......................................................................................................................................21 Summary of Evidence ...............................................................................................................................22 Excluded Articles......................................................................................................................................26 Study Quality ............................................................................................................................................27 Study Results ............................................................................................................................................28 Recommendation 4 ......................................................................................................................................34 Summary of Evidence ...............................................................................................................................35 Excluded Articles......................................................................................................................................38 Study Quality ............................................................................................................................................39 Recommendation 5 ......................................................................................................................................42 Summary of Evidence ...............................................................................................................................44 Excluded Articles......................................................................................................................................50 Study Quality ............................................................................................................................................55 Recommendation 6 ......................................................................................................................................59 Recommendation 7 ......................................................................................................................................60 Recommendation 8 ......................................................................................................................................61 Percutaneous vs Open Repair ...................................................................................................................62 Summary of Evidence- Percutaneous vs. Open ........................................................................................63 Limited Open vs Open Repair ..................................................................................................................64 xiii Summary of Evidence- Limited Open vs. Open .......................................................................................65 Excluded Articles......................................................................................................................................67 Study Quality ............................................................................................................................................69 Study Results ............................................................................................................................................73 Recommendation 9 ......................................................................................................................................77 Autograft Tissue vs Open Repair..............................................................................................................77 Augmentation with Synthetic Tissue vs Open Repair ..............................................................................78 Summary of Evidence ...............................................................................................................................78 Excluded Articles......................................................................................................................................80 Study Quality ............................................................................................................................................82 Study Results ............................................................................................................................................86 Recommendation 10 ....................................................................................................................................90 Excluded Studies ......................................................................................................................................90 Recommendation 11 ....................................................................................................................................91 Summary of Evidence ...............................................................................................................................94 Summary of Complications ......................................................................................................................99 Excluded Articles....................................................................................................................................101 Study Quality ..........................................................................................................................................102 Study Results ..........................................................................................................................................111 Recommendation 12 ..................................................................................................................................116 Summary of Evidence .............................................................................................................................117 Summary of Complications ....................................................................................................................123 Excluded Articles....................................................................................................................................125 Study Quality ..........................................................................................................................................126 Study Results ..........................................................................................................................................131 Recommendation 13 ..................................................................................................................................136 Summary of Evidence .............................................................................................................................136 Excluded articles .....................................................................................................................................137 Recommendation 14 ..................................................................................................................................138 Summary of Evidence .............................................................................................................................138 Excluded Articles....................................................................................................................................145 Study Quality ..........................................................................................................................................147 Recommendation 15 ..................................................................................................................................150 Summary of Evidence .............................................................................................................................151 Excluded Articles....................................................................................................................................153 Study Quality ..........................................................................................................................................155 Recommendation 16 ..................................................................................................................................160 Summary of Evidence .............................................................................................................................160 Excluded Articles....................................................................................................................................163 Study Quality ..........................................................................................................................................163 Future Research ........................................................................................................................................166 Appendix I ..................................................................................................................................................168 Work Group ............................................................................................................................................168 Appendix II ................................................................................................................................................169 xiv Time from rupture to treatment ..............................................................................................................169 Appendix III ...............................................................................................................................................173 AAOS Bodies That Approved This Clinical Practice Guideline ............................................................173 Documentation of Approval ...................................................................................................................174 Appendix IV ...............................................................................................................................................175 Literature Searches for Primary Studies .................................................................................................175 Appendix V ................................................................................................................................................177 Study Attrition Flowchart .......................................................................................................................177 Appendix VI ...............................................................................................................................................178 Data Extraction Elements .......................................................................................................................178 Appendix VII .............................................................................................................................................179 Judging the Quality of Diagnostic Studies ..............................................................................................179 Judging the Quality of Treatment Studies ..............................................................................................180 Appendix VIII ............................................................................................................................................182 Form for Assigning Strength of Recommendation (Interventions) ........................................................182 Appendix IX ...............................................................................................................................................184 Voting by the Nominal Group Technique ..............................................................................................184 Appendix X ................................................................................................................................................185 Structured Peer Review Form .................................................................................................................185 Appendix XI ...............................................................................................................................................188 Peer Review Panel ..................................................................................................................................188 Public Commentary ................................................................................................................................189 Appendix XII .............................................................................................................................................190 Description of Symbols Used in Tables..................................................................................................190 Appendix XIII ............................................................................................................................................191 Conflict of Interest ..................................................................................................................................191 Appendix XIV ............................................................................................................................................192 References ..............................................................................................................................................192 Excluded articles after full text review ...................................................................................................197 xv List of Tables Table 1 Strength of Recommendation Descriptions ........................................................... 9 Table 2 AAOS Guideline Language ................................................................................. 10 Table 3. Excluded Articles ................................................................................................ 14 Table 4. Study Quality ...................................................................................................... 15 Table 5. Sensitivity and specificity of Palpation, Calf Squeeze and Matles tests ............ 16 Table 6. Excluded Articles ................................................................................................ 18 Table 7. Study Quality ...................................................................................................... 19 Table 8. Sensitivity and Specificity .................................................................................. 20 Table 9. Operative vs. Cast – Function ............................................................................. 22 Table 10. Operative vs. Cast – Pain .................................................................................. 22 Table 11. Operative vs. Cast – Return to Work ................................................................ 23 Table 12. Operative vs. Cast - Return to Sport ................................................................ 23 Table 13. Operative vs. Cast - Rerupture .......................................................................... 23 Table 14. Operative vs. Cast - Satisfaction ....................................................................... 24 Table 15. Operative vs. Cast – Complications.................................................................. 24 Table 16. Systematic Review Summary ........................................................................... 25 Table 17. Excluded Articles .............................................................................................. 26 Table 18. Study Quality .................................................................................................... 27 Table 19. Open vs. Cast - Function................................................................................... 28 Table 20. Cast vs. Open Repair - Pain .............................................................................. 29 Table 21. Operative vs. Cast - Return to Work................................................................. 30 Table 22. Operative vs. Cast - Return to Sport ................................................................. 31 Table 23. Operative vs. Cast - Rerupture .......................................................................... 31 Table 24 Cast vs. Open - Complications .......................................................................... 32 Table 25. Cast + Functional Brace vs. Cast - Rerupture................................................... 35 Table 26. Summary of Results - Case Series .................................................................... 35 Table 27. Summary of Systematic Reviews ..................................................................... 35 Table 28. Functional Bracing – Satisfaction (VAS) ......................................................... 36 Table 29. Functional Bracing - Satisfaction (%) .............................................................. 36 Table 30. Functional Bracing - Pain ................................................................................. 36 Table 31. Functional Bracing - Function .......................................................................... 36 Table 32. Functional Bracing - Strength ........................................................................... 37 Table 33. Functional Bracing - Return to Work and Sports ............................................. 37 Table 34. Functional Bracing - Return to Work and Sports (days) .................................. 37 Table 35. Functional Bracing - Complications ................................................................. 38 Table 36. Functional Bracing - Rerupture ........................................................................ 38 Table 37. Functional Bracing - Excluded Studies ............................................................ 38 Table 38. Study Quality - Randomized Control Trials ..................................................... 39 Table 39. Study Quality - Non-Randomized Comparative Study .................................... 39 Table 40. Study Quality - Case Series .............................................................................. 40 Table 41. Open Repair – All Outcomes ............................................................................ 44 Table 42. Open Repair - Return to work........................................................................... 44 Table 43. Open Repair - Activities of daily living............................................................ 45 Table 44. Open Repair- Mean time until return to athletic activity .................................. 45 Table 45. Open Repair- Percent of patients able to return to activities of daily living .... 46 xvi Table 46. Open Repair- Percent of patients able to return to work .................................. 46 Table 47. Open Repair- Percent of patients able to return to sports ................................. 46 Table 48: Open Repair- Percent of patients with pain ..................................................... 47 Table 49. Open Repair- Percent of patients able to complete functional activities .......... 47 Table 50. Open Repair- Percent of patients with excellent satisfaction ........................... 47 Table 51. Minimally Invasive Repair- All outcomes....................................................... 48 Table 52. Minimally Invasive Repair- Percent of Patients able to return to activity........ 48 Table 53. Minimally Invasive Repair - Percent of patients able to return to sports ......... 49 Table 54. Minimally Invasive Repair - Satisfaction ......................................................... 49 Table 55. Minimally Invasive Repair - Mean time until return to activity ....................... 49 Table 56. Minimally Invasive Repair-Percent of patients able to return to sports ........... 49 Table 57. Minimally Invasive Repair-Percent of patients able to return to work............. 50 Table 58. Minimally Invasive Repair-Pain ....................................................................... 50 Table 59. Excluded Articles .............................................................................................. 50 Table 60. Study Quality .................................................................................................... 55 Table 61. Percutaneous and Limited Open vs. Open - Global Outcomes ........................ 63 Table 62. Percutaneous vs. Open - Return to Activities and Function ............................. 63 Table 63. Percutaneous vs. Open - Satisfaction ............................................................... 63 Table 64. Percutaneous vs. Open- Complications ........................................................... 63 Table 65. Percutaneous vs. Open- Rerupture................................................................... 64 Table 66. Minimally Invasive vs. Open- Pain ................................................................. 65 Table 67. Minimally Invasive vs. Open- Global Outcomes ............................................ 65 Table 68. Limited Open vs. Open- Return to Activity .................................................... 65 Table 69. Mini-Open vs. Open- Symptoms ..................................................................... 65 Table 70. Limited Open Repair vs. Open - Complications............................................... 66 Table 71. Mini-Open vs. Open – Rerupture ..................................................................... 66 Table 72. Excluded Studies - All Operative Techniques .................................................. 67 Table 73. Study Quality - RCTs ....................................................................................... 69 Table 74. Quality of Studies - Comparative Studies......................................................... 71 Table 75. Limited open vs. Open - Global Outcomes .................................................... 73 Table 76. Percutaneous vs. Open - Return to Activities ................................................... 73 Table 77. Percutaneous vs. Open - Satisfaction ................................................................ 73 Table 78. Percutaneous vs. Open - Complications ........................................................... 73 Table 79. Minimally Invasive vs. Open- Pain ................................................................. 74 Table 80. Minimally Invasive vs. Open- Global Outcomes ............................................ 74 Table 81. Minimally Invasive vs. Open - Function .......................................................... 74 Table 82. Minimally Invasive vs. Open - Complications ................................................. 75 Table 83. Minimally Invasive vs. Open - Symptoms ....................................................... 75 Table 84. Minimally Invasive vs. Open - Return to Sport ................................................ 76 Table 85. Minimally Invasive vs. Open - Complications ................................................. 76 Table 86. Autograft vs. Open - Pain and Stiffness ........................................................... 78 Table 87. Autograft vs. Open - Satisfaction ..................................................................... 78 Table 88. Autograft - Return to Activities and Sports ..................................................... 78 Table 89. Autograft vs. Open - Footwear Restrictions ..................................................... 79 Table 90. Autograft vs. Open - Hospitalization and Immobilization ............................... 79 Table 91. Autograft vs. Open - Complications ................................................................. 79 xvii Table 92. Excluded Studies - Allograft............................................................................. 80 Table 93. Excluded Studies - Autograft ............................................................................ 80 Table 94. Excluded Studies - Synthetic Tissue ................................................................. 81 Table 95- Biologic Adjuncts ............................................................................................. 81 Table 96. Study Quality – Autograft RCTs ...................................................................... 82 Table 97. Study Quality - Autograft Comparative Studies .............................................. 83 Table 98. Study Quality - Synthetic Tissue Case Series .................................................. 85 Table 99 Autograft vs. Open Pain and Stiffness ............................................................... 86 Table 100. Autograft vs. Open - Satisfaction ................................................................... 86 Table 101. Autograft vs. Open - Return to Sports ............................................................ 87 Table 102. Autograft vs. Open - Return to Activities ....................................................... 87 Table 103. Autograft vs. Open - Footwear Restrictions ................................................... 87 Table 104. Autograft vs. Open - Hospitalization vs. Immobilization ............................... 88 Table 105. Autograft vs. Open - Complications ............................................................... 88 Table 106. Synthetic Tissue - Results ............................................................................... 89 Table 107. Antithrombotic Treatment - Excluded Studies ............................................... 90 Table 108: Description of treatment groups .................................................................... 92 Table 109 Time until return to activity ............................................................................. 94 Table 110 Pain .................................................................................................................. 94 Table 111 Function ........................................................................................................... 96 Table 112 EuroQoL, Rand-36........................................................................................... 97 Table 113 Patient Subjective Results................................................................................ 97 Table 114 Reruptures ........................................................................................................ 98 Table 115 Reported Complications .................................................................................. 99 Table 116 Systematic Reviews ....................................................................................... 100 Table 117 Article Inclusion List- Early weight bearing vs. non-weight bearing............ 101 Table 118. Quality- Weight bearing vs. non-weight bearing- RCT ............................... 102 Table 119. Quality- Weight bearing vs. non-weight bearing- Comparative.................. 105 Table 120 Study Data: Weight Bearing vs. Non-Weight Bearing .................................. 111 Table 121. Description of Treatment Groups ................................................................. 117 Table 122. Time to Return to Activity ............................................................................ 117 Table 123. Pain .............................................................................................................. 119 Table 124. Function ........................................................................................................ 119 Table 125. EuroQoL, E5D, Ankle Performance Score ................................................... 120 Table 126. Patient opinion of results .............................................................................. 121 Table 127. Footwear restrictions..................................................................................... 122 Table 128. Rerupture ...................................................................................................... 122 Table 129. Early Motion vs. Cast - Complications......................................................... 123 Table 130. Systematic Reviews ...................................................................................... 124 Table 131. Mobilization vs. Immobilization Included Articles ...................................... 125 Table 132. Mobilization vs. Immobilization Quality...................................................... 126 Table 133. Mobilization vs. Immobilization Study Data ................................................ 131 Table 134. Post Operative Physiotherapy Regiments .................................................... 136 Table 135. Excluded Articles .......................................................................................... 137 Table 136. Non-Operative treatment - Percent of patients able to return to work.......... 138 Table 137. Non-Operative Treatment -Percent of patients able to return to ADL ......... 139 xviii Table 138. Operative Treatment - Percent of patients returning to ADL ....................... 139 Table 139. Operative Treatment - Percent of patients able to return to work ................ 140 Table 140. Non-Operative Treatment - Mean time until return to work ........................ 142 Table 141. Non-Operative Treatment - Mean time until return to walking.................... 142 Table 142. Operative Treatment - Mean time to return to ADL ..................................... 143 Table 143. Operative Treatment - Mean time until return to work ................................ 144 Table 144. Excluded Articles .......................................................................................... 145 Table 145. Patient return to activities of daily living...................................................... 147 Table 146. Operative Treatment - Return to Recreational Activity................................ 151 Table 147. Operative Treatment - Return to sports ........................................................ 151 Table 148. Operative Treatment - Mean time to return to athletic activity .................... 153 Table 149. Excluded Articles .......................................................................................... 153 Table 150. Return to sports ............................................................................................. 155 Table 151. Non-Operative Treatment - Percent of patients returning to athletic activity ......................................................................................................................................... 160 Table 152. Non-Operative Treatment - Mean time until patients return to athletic activity ......................................................................................................................................... 162 Table 153. Excluded studies ........................................................................................... 163 Table 154. Study Quality ................................................................................................ 163 Table 155. Time from injury to treatment ..................................................................... 169 xix I. INTRODUCTION OVERVIEW This clinical practice guideline is based on a systematic review of published studies on the treatment of acute Achilles tendon rupture in adults. Adults were defined as older than 19 years of age for this guideline. Acute Achilles tendon ruptures were defined for the literature search as those treated within the first six weeks of injury to capture all applicable literature; the patient population of the majority of studies included in this guideline are patients treated within the first two weeks of injury (See Appendix II). In addition to providing practice recommendations, this guideline also highlights gaps in the literature and areas that require future research. This guideline is intended to be used by all appropriately trained surgeons and all qualified physicians diagnosing and treating Achilles tendon ruptures. It is also intended to serve as an information resource for decision makers and developers of practice guidelines and recommendations. GOALS AND RATIONALE The purpose of this clinical practice guideline is to help improve treatment based on the current best evidence. Current evidence-based practice (EBP) standards demand that physicians use the best available evidence in their clinical decision making. To assist in this, this clinical practice guideline consists of a systematic review of the available literature regarding the treatment of Achilles tendon ruptures. The systematic review detailed herein was conducted between December 2008 and June 2009 and demonstrates where there is good evidence, where evidence is lacking, and what topics future research must target in order to improve the treatment of patients with acute Achilles tendon ruptures. AAOS staff and the physician work group systematically reviewed the available literature and subsequently wrote the following recommendations based on a rigorous, standardized process. Musculoskeletal care is provided in many different settings by many different providers. We created this guideline as an educational tool to guide qualified physicians through a series of treatment decisions in an effort to improve the quality and efficiency of care. This guideline should not be construed as including all proper methods of care or excluding methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment must be made in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. INTENDED USERS This guideline is intended to be used by orthopaedic surgeons and all qualified physicians managing patients with acute Achilles tendon rupture. Typically, orthopaedic surgeons will have completed medical training, a qualified residency in orthopaedic surgery, and some may have completed additional sub-specialty training. It is also intended to serve as an information resource for professional healthcare practitioners and developers of practice guidelines and recommendations. Diagnosis and treatment for patients with acute Achilles tendon rupture are based on the assumption that decisions are predicated on 1 v1.0 12.04.09 patient and physician mutual communication including discussion of available treatments and procedures applicable to the individual patient. Once the patient has been informed of available therapies and has discussed these options with his/her physician, an informed decision can be made. Clinician input based on experience with both conservative management and surgical skills increases the probability of identifying patients who will benefit from specific treatment options. PATIENT POPULATION This document addresses the diagnosis and treatment of acute Achilles tendon rupture in adults (defined as patients 19 years of age and older). INCIDENCE The incidence of Achilles tendon ruptures has been estimated to range from an annual average of 5.5 ruptures to 9.9 ruptures per 100,000 people in North America (Edmonton, Canada).1 Studies of European communities report comparable values ranging from 6 to 18 ruptures per 100,000 people.1-4 BURDEN OF DISEASE Those afflicted with an acute Achilles tendon rupture face a healing period that requires time away from work and limited athletic activity. Time away from work may impact the patient financially and limiting activity may impact the patient’s health.5 ETIOLOGY Most acute Achilles tendon ruptures are traumatic in origin. Some studies have shown that ruptured Achilles tendons have occult degeneration.3 RISK FACTORS Most ruptures of the Achilles tendons occur during sports activities, are more common in males in the third or fourth decade of life, and occur more frequently on the left side.1 EMOTIONAL AND PHYSICAL IMPACT OF ACHILLES TENDON RUPTURE Acute Achilles tendon rupture often results in sudden pain in the affected leg, the inability to bear weight and noticeable weakness of the affected ankle.3 The injury often results in the patient’s inability to walk or perform their regular activities of daily living. Patients face possible deformity if the tendon does not heal correctly and a substantial recovery period. Possible complications associated with Achilles tendon rupture include rerupture and, in cases of surgical repair, infection. POTENTIAL BENEFITS, HARMS, AND CONTRAINDICATIONS The aim of treatment is pain relief and improvement or maintenance of the patient’s functional status. Long term results were often not available and complications varied by study (frequently they were not reported) in the literature available for this guideline. Most treatments are associated with some known risks, especially invasive and operative treatments. In addition, contraindications vary widely based on the treatment administered. Therefore, discussion of available treatments and procedures applicable to 2 v1.0 12.04.09 the individual patient rely on mutual communication between the patient and physician, weighing the potential risks and benefits for that patient. II. METHODS Each recommendation in this clinical practice guideline is based on a systematic review of the relevant medical literature. We developed systematic reviews for this guideline because these reviews employ specific processes designed to minimize bias in the selection, summary, and analysis of this literature.6, 7 In referring to bias, we explicitly mean both the biases that can arise from financial conflicts of interest and biases that can arise from intellectual conflicts if interest. This section of the present document describes how we conducted our systematic reviews and how the guideline was developed. Accordingly, in this section we describe our strategies for finding relevant literature, our criteria for selecting articles to include in this guideline, how we extracted data, how we appraised and graded the evidence, our methods of statistical analysis, and the review and approval steps this guideline went through. Elsewhere in this document, we provide extensive documentation so that interested readers can assure themselves that we attempted to combat bias wherever possible. This guideline and the underlying systematic reviews were prepared by an AAOS physician work group with the assistance of the AAOS Clinical Practice Guidelines Unit in the Department of Research and Scientific Affairs at the AAOS (Appendix I). The work group met on December 13, 2008 to establish the guideline’s scope. The work group met again on July 31 and August 1, 2009 to write and vote on the final recommendations and rationales for each recommendation. The resulting draft guidelines were then peer-reviewed, subsequently sent for public commentary, and then sequentially approved by the AAOS Evidence Based Practice Committee, AAOS Guidelines and Technology Oversight Committee, AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors (see Appendix III for a description of the AAOS bodies involved in the approval process) FORMULATING PRELIMINARY RECOMMENDATIONS The work group began work on this guideline by constructing a set of preliminary recommendations. These recommendations specify [what] should be done in [whom], [when], [where], and [how often or how long]. They function as questions for the systematic review that underpins each preliminary recommendation, and they do not function as final recommendations or conclusions. Preliminary recommendations do not need to be true. Once established, these a priori preliminary recommendations cannot be modified until the final work group meeting. The a priori and inviolate nature of the preliminary recommendations combats bias by preventing a “change in course” if a systematic review yields results that are not to someone’s liking. The results of each systematic review are presented and discussed at the final work group meeting. At this time the preliminary recommendations are modified in response to the evidence in the systematic review. All 3 v1.0 12.04.09 of the systematic reviews conducted for a given guideline are presented in it and, in general, all preliminary recommendations are modified. STUDY INCLUSION CRITERIA We developed a priori article inclusion criteria for our review. These criteria are our “rules of evidence” and articles that do not meet them are, for the purposes of this guideline, not evidence. To be included in our systematic reviews (and hence, in this guideline) an article had to be a report of a study that: Evaluated a treatment for acute Achilles tendon rupture. Acute Achilles tendon ruptures are defined as a rupture treated within zero to six weeks post injury. Was a full report of a clinical study and was published in the peer reviewed literature Was an English language article published after 1965 Was not a cadaveric, animal, in vitro, or biomechanical study Was not a retrospective case series, medical records review, meeting abstract, unpublished study report, case report, historical article, editorial, letter, or commentary Was the most recent report of a study or the report with the largest number of enrolled patients in a study with multiple publications Enrolled ≥ 10 patients in each of its study groups Enrolled a patient population comprised of at least 80% of patients with acute Achilles tendon rupture Reported quantified results Must have followed 50% or more of its patients on at least one outcome; if less than 80% follow up the outcome was down graded. Study must use validated outcome measures When considering studies for inclusion, we included only the best available evidence. Accordingly, we first included Level I evidence. In the absence of two or more studies of this Level, we sequentially searched for and included Level II through Level IV evidence, and did not proceed to a lower level if there were two or more studies of a higher level. For example, if there were two Level II studies that addressed a recommendation, we did not include Level III or IV studies. OUTCOMES CONSIDERED Clinical studies often report many different outcomes. We included only patient-oriented outcomes when they were available. As the term implies, patient-oriented outcomes are 4 v1.0 12.04.09 outcomes that matter to the patient. “They tell clinicians, directly and without the need for extrapolation, that a diagnostic, therapeutic, or preventive procedure helps patients live longer or live better.”8 Examples of patient-oriented outcomes include pain and quality of life. We included surrogate outcomes only when patient-oriented outcomes were not available. Surrogate outcomes are laboratory or other measurements that are used as substitutes for how a patient feels, functions, or survives.9 Radiographic results are an example of a surrogate outcome. We only included data for an outcome if ≥ 50% of the patients were followed for that outcome. For example, some studies report short-term outcomes data on nearly all enrolled patients, and report longer-term data on less than half of the enrolled patients. In such cases, we did not include the longer-term data. Additionally, we downgraded the Level of Evidence by one in instances where 50% to ≤80% of patients were followed. For example, if an otherwise perfect randomized controlled trial reported data on all enrolled patients one week after patients received a treatment but reported data on only 60% of patients one year later, we considered data from the later follow-up time as Level II evidence. We only included data for outcomes reporting the average length of time to return to an activity if >80 % of the patients were included in the calculation. For example, some studies report the mean time for return to work as 6 weeks but are only including data for patients who have actually returned to work and are ignoring patients who are unable to return. An outcome such as this would not be included. LITERATURE SEARCHES We attempted to make our searches for articles comprehensive. Using comprehensive literature searches ensures that the evidence we considered for this guideline is not biased for (or against) any particular point of view. We searched for articles published from January 1966 to June 2009. Strategies for searching electronic databases were constructed by a Medical Librarian and reviewed by the work group. The search strategies we used are provided in Appendix IV. We searched six electronic databases; PubMed, EMBASE, CINAHL, The Cochrane Library, The National Guidelines Clearinghouse and TRIP database. All searches of electronic databases were supplemented with manual screening of bibliographies of all retrieved publications. We also searched the bibliographies of recent systematic reviews and other review articles for potentially relevant citations. Finally, a list of potentially relevant studies not identified by our searches was provided by the work group members. Fifty-six studies met the inclusion criteria and were included. A study attrition diagram (provided in Appendix V) documents, for each recommendation, the number of articles we identified, where we identified these articles, the number of articles we included, and the number of articles we excluded. 5 v1.0 12.04.09 DATA EXTRACTION Data elements extracted from studies were defined in consultation with the physician work group. Two analysts completed data extraction independently for all studies. The evidence tables were audited by the work group. Disagreements about the accuracy of extracted data were resolved by consensus. The elements extracted are provided in Appendix VI. The use of extracted data in our systematic reviews is another of our methods to combat bias. It ensures that our results are based on the numerical results reported in published articles and not on the authors’ conclusions in the “Discussion Sections” of their articles. Such author conclusions can be influenced by bias. JUDGING THE QUALITY OF EVIDENCE Determining the quality of the included evidence is vitally important when preparing any evidence-based work product. Doing so conveys the amount of confidence one can have in any study’s results. One has more confidence in high quality evidence than in low quality evidence. We assessed the quality of the evidence for each outcome at each time point reported in a study. We did not simply assess the overall quality of a study. Our approach follows the recommendations of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) working group10 as well as others.11 We evaluated quality on a per outcome basis rather than a per study basis because quality is not necessarily the same for all outcomes and all follow-up times reported in a study. For example, a study might report results immediately after patients received a given treatment and after some period of time has passed. Often, nearly all enrolled patients contribute data at early follow-up times but, at much later follow-up times, only a few patients may contribute data. One has more confidence in the earlier data than in the later data. The fact that we would assign a higher quality score to the earlier results reflects this difference in confidence. We assessed the quality of treatment studies using a two step process. First, we assigned a Level of Evidence to all results reported in a study based solely on that study’s design. Accordingly, all data presented in randomized controlled trials were initially categorized as Level I evidence, all results presented in non-randomized controlled trials and other prospective comparative studies were initially categorized as Level II, all results presented in retrospective comparative and case-control studies were initially categorized as Level III, and all results presented in case-series reports were initially categorized as Level IV. We next assessed each outcome at each reported time point using a quality questionnaire and, when quality standards were not met, downgraded the Level of evidence (for this outcome at this time point) by one level (Appendix VII). In studies investigating a diagnostic test, we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) instrument to identify potential bias and assess variability and the quality of reporting in studies reporting the effectiveness of diagnostic techniques. We utilized a two step process to assess the quality of diagnostic studies. All 6 v1.0 12.04.09 studies enrolling a prospective cohort of patients are initially categorized as Level I studies. Any study that did not enroll the appropriate spectrum of patients (e.g. casecontrol studies) was initially categorized as a Level IV study. A study that we determined contained methodological flaws (i.e. QUADAS question answered ‘no’) that introduce bias were downgraded in a cumulative manner for each known bias (Appendix VII). For example, a study that is determined by the QUADAS instrument to have two biases is downgraded to Level III and a study that is determined to have four or more biases is downgraded to a Level V study. Those studies that do not sufficiently report their methods for a potential bias are downgraded to Level II since we are unable to determine if the bias did or did not bias the results of the study. Assigning a Level of Evidence on the basis of study design plus other quality characteristics ties the Levels of Evidence we report more closely to quality than Levels of Evidence based only on study design. Because we tie quality to Levels of Evidence, we are able to characterize the confidence one can have in their results. Accordingly, we characterize the confidence one can have in Level I evidence as high, the confidence one can have in Level II and III evidence as moderate, and the confidence one can have in Level IV and V evidence as low. DEFINING THE STRENGTH OF THE RECOMMENDATIONS Judging the quality of evidence is only a stepping stone towards arriving at the strength of the guideline recommendation. Unlike Levels of Evidence (which apply only to a given result at a given follow-up time in a given study) strength of the recommendation takes into account the quality, quantity, and applicability of the available evidence. Strength of the recommendation also takes into account the trade-off between the benefits and harms of a treatment or diagnostic procedure, and the magnitude of a treatment’s effect. The strength of a recommendation expresses the degree of confidence one can have in a recommendation. As such, the strength expresses how possible it is that a recommendation will be overturned by future evidence. It is very difficult for future evidence to overturn a recommendation that is based on many high quality randomized controlled trials that show a large effect. It is much more likely that future evidence will overturn recommendations derived from a few small case series. Consequently, recommendations based on the former kind of evidence are rated as “strong” and recommendations based on the latter kind of evidence are given strength of recommendation of “limited”. To develop the strength of a recommendation, AAOS staff first assigned a preliminary strength rating for each recommendation that took only the quality and quantity of the available evidence into account (see Table 1).Work group members then modified the preliminary strength rating using the ‘Form for Assigning Grade of Recommendation (Interventions)’ shown in Appendix VIII. This form is based on recommendations of the GRADE Working group10 and requires the work group to consider the harms, benefits, and critical outcomes associated with a treatment. It also requires the work group to evaluate the applicability of the evidence. The final strength of the recommendation is assigned by the physician work group, which modifies the preliminary strength rating on 7 v1.0 12.04.09 the basis of these considerations. 8 v1.0 12.04.09 Table 1 Strength of Recommendation Descriptions Statement Rating Strong Moderate Limited Inconclusive Description of Evidence Strength Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single Moderate quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that wellconducted studies show little clear advantage to one approach versus another. Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Consensus1 The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. Implication for Practice Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria. 1 The AAOS will issue a consensus-based recommendation only when the service in question has virtually no associated harm and is of low cost (e.g. a history and physical) or when not establishing a recommendation could have catastrophic consequences. 9 v1.0 12.04.09 Each recommendation was written using language that accounts for the final strength of the recommendation. This language, and the corresponding strength of recommendation, is shown in Table 2. Table 2 AAOS Guideline Language Strength of Recommendation Guideline Language We recommend Strong We suggest Moderate Is an option Limited We are unable to recommend for or against In the absence of reliable evidence, it is the opinion of this work group Inconclusive Consensus CONSENSUS DEVELOPMENT The recommendations and their strength were voted on using a structured voting technique known as the nominal group technique.12 We present details of this technique in Appendix . Voting on guideline recommendations was conducted using a secret ballot and work group members were blinded to the responses of other members. If disagreement between work group members was significant, there was further discussion to see whether the disagreement(s) could be resolved. Up to three rounds of voting were held to attempt to resolve disagreements. If disagreements were not resolved following three voting rounds, no recommendation was adopted. Lack of agreement is a reason that the strength for some recommendations is labeled “Inconclusive.” STATISTICAL METHODS When possible, we report the results of the statistical analyses conducted by the authors of the included studies. In some circumstances, statistical testing was not conducted; however, the authors reported sufficient quantitative data, including measures of dispersion or patient level data for statistical testing. In these circumstances we used the statistical program STATA (StatCorp LP, College Station, Texas) to conduct our own analysis to interpret the results of a study. P-values < 0.05 were considered statistically significant. Any statistical analysis conducted by the AAOS authors is denoted in the tables. STATA was also used to determine 95% confidence intervals, using the method of Wilson, when authors of the included studies reported counts or proportions. The program was also used to determine the magnitude of the treatment effect. For data reported as means (and associated measures of dispersion) we calculated a standardized mean difference by the method of Hedges and Olkin.13 For proportions, we calculated the odds ratio as a measure of treatment effect. When no events occur (“zero event”) in a proportion, the variance of the arcsine difference was used to determine statistical significance (p < 0.05).14 10 v1.0 12.04.09 We used the program TechDig 2.0 (Ronald B. Jones, Mundelein, Illinois) to estimate means and variances from studies presenting data only in graphical form. When published studies only reported the median, range, and size of the trial, we estimated their means and variances according to a published method.15 PEER REVIEW The draft of the guideline and evidence report were peer reviewed by outside specialty organizations that were nominated by the physician work group prior to the development of the guideline. Peer review was accomplished using a structured peer review form (Appendix X). In addition, the physician members of the AAOS Guidelines and Technology Oversight Committee, the Evidence Based Practice Committee and the Chairpersons of the AAOS Occupational Health and Workers’ Compensation Committee and the Medical Liability Committee were given the opportunity to provide peer review of the draft document. We forwarded the draft guideline to a total of 38 peer reviewers and 17 returned reviews. The disposition of all non-editorial peer review comments was documented and the guideline was modified in response to peer review. The peer reviews and the responses to them accompanied this guideline through the process of public commentary and the subsequent approval process. Peer reviewing organizations and peer reviewing individuals are listed in this document if they explicitly agree to allow us to publish this information (Appendix X). Peer review of an AAOS guideline does not imply endorsement. This is clearly stated on the structured review form sent to all peer reviewers and is also posted within the guideline. Endorsement cannot be solicited during the peer review process because the documents may still undergo substantial change as a result of both the peer review and public commentary processes. In addition, no guideline can be endorsed by specialty societies outside of the Academy until the AAOS Board of Directors has approved it. Organizations that provide members who participate on the work group or peer review of a draft guideline will be solicited for endorsement once the document has completed the full review and approval processes. PUBLIC COMMENTARY After modifying the draft in response to peer review, the guideline was submitted for a thirty-day period of “Public Commentary.” Commentators consist of members of the AAOS Board of Directors (BOD), members of the Council on Research, Quality Assessment, and Technology (CORQAT), members of the Board of Councilors (BOC), and members of the Board of Specialty Societies (BOS). Based on these bodies, up to 185 commentators had the opportunity to provide input into the development of this guideline. Of these, 4 returned public comments. For this guideline, outside specialty societies could post the confidential draft of the guideline to their “member only” website. The responses garnered from these postings were compiled by the specialty society and submitted as one succinct public commentary. 11 v1.0 12.04.09 In addition, members of the AAOS Board of Specialties (BOS) and Board of Councilors (BOC) were encouraged to provide input; including encouragement to seek input from colleagues not necessarily members of the BOS or BOC. As a result, the opportunity to comment on this guideline exceeds the number of public commentators for previously published AAOS guidelines as well as the numbers listed above. THE AAOS GUIDELINE APPROVAL PROCESS In response to the non-editorial comments submitted during the period of public commentary, the draft was again modified by the AAOS Clinical Practice Guidelines Unit and physician work group members. The AAOS Guidelines and Technology Oversight Committee, the AAOS Evidence-based Practice Committee, the AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors approved the final guideline draft. Descriptions of these bodies are provided in Appendix III. REVISION PLANS This guideline represents a cross-sectional view of current treatment and/or diagnosis and may become outdated as new evidence becomes available. This guideline will be revised in accordance with this new evidence, changing practice, rapidly emerging treatment options, and new technology. This guideline will be updated or withdrawn in five years in accordance with the standards of the National Guideline Clearinghouse. GUIDELINE DISSEMINATION PLANS The primary purpose of the present document is to provide interested readers with full documentation about not only our recommendations, but also about how we arrived at those recommendations. This document is also posted on the AAOS website at http://www.aaos.org/research/guidelines/guide.asp. Shorter versions of the guideline are available in other venues. Publication of most guidelines is announced by an Academy press release, articles authored by the work group and published in the Journal of the American Academy of Orthopaedic Surgeons, and articles published in AAOS Now. Most guidelines are also distributed at the AAOS Annual Meeting in various venues such as on Academy Row and at Committee Scientific Exhibits. Selected guidelines are disseminated by webinar, an Online Module for the Orthopeadic Knowledge Online website, Radio Media Tours, Media Briefings, and by distributing them at relevant Continuing Medical Education (CME) courses and at the AAOS Resource Center. Other dissemination efforts outside the AAOS include submitting the guideline to the National Guideline Clearinghouse and distributing the guideline at other medical specialty societies’ meetings. 12 v1.0 12.04.09 III. RECOMMENDATIONS AND SUPPORTING EVIDENCE RECOMMENDATION 1 In the absence of the reliable evidence, it is the opinion of this work group that a detailed history and physical exam be performed. The physical examination should include two or more of the following tests to establish the diagnosis of acute Achilles tendon rupture: o Clinical Thompson test (Simmonds squeeze test) o Decreased ankle plantar flexion strength o Presence of a palpable gap (defect, loss of contour) o Increased passive ankle dorsiflexion with gentle manipulation AAOS Strength of Recommendation – Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. Rationale: A systematic review of the literature did not identify adequate evidence for or against the use of specific history and physical examination findings to confirm the diagnosis of acute Achilles tendon rupture. There was only one level V study16 identified that did not provide adequate data in support of any individual or combination of the physical tests. The prompt and accurate diagnosis of acute Achilles tendon rupture is essential to providing patients with timely, effective, and appropriate care. A history and physical examination adds no cost or risk to patients. The work group therefore agreed that an opinion-based recommendation is warranted. Supporting Evidence: One Level V prospective study that enrolled patients with unilateral complete Achilles tendon tears was included.16 SUMMARY OF EVIDENCE The study16 used visual inspection at surgery as the gold standard for the diagnosis in patients who had open repair. The study author also used clinical exam, ultrasound and MRI as the reference standard for diagnosis when deciphering if patients had an Achilles tendon tear and to confirm the extent of the tear in patients treated non-operatively. Healthcare providers were not routinely blinded to the results of any given test. All patients received a physical examination; palpation (presence of a gap) and the calf 13 v1.0 12.04.09 squeeze test (Thompson/Simmonds squeeze test) were performed by the author in all patients. The author performed the Matles test (increased passive ankle dorsiflexion) on 107 of 174 patients. The study author reported sensitivities and specificities for the tests based on the 133 patients treated with open repair and the 28 patients treated who did not have an Achilles tendon rupture. The author reported these test results individually. He did not consider if incremental value exists for any combination of the given physical tests when the tests are all performed during the physical examination. EXCLUDED ARTICLES Table 3. Excluded Articles Author Title Exclusion Reason Copeland SA; Rupture of the Achilles tendon: a new clinical test Not relevant Matles AL Rupture of the tendo achilles: another diagnostic sign Commentary 14 v1.0 12.04.09 Selection criteria described Appropriate reference standard Disease progression bias avoided Partial verification bias avoided Differential verification bias avoided Incorporation bias avoided Index test execution described Reference standard execution described Test review bias avoided Diagnostic review bias avoided Clinical review bias avoided Uninterruptable/Intermediate test result(s) reported Withdrawals explained Index Test Reference Standard Spectrum bias avoided STUDY QUALITY Table 4. Study Quality Palpation Open Repair,Ultrasound or MRI or Clinical tests X ○ ● ● ● ○ ● ● ● ● ○ ● ● ● Open Repair, Ultrasound or MRI or Clinical tests X ○ ● ● ● ○ ● ● ● ● ○ ● ● ● Open Repair, Ultrasound or MRI or Clinical tests X ○ ● ● ● ○ ● ● ● ● ○ ● ● ○ ● = Yes ○ = No X = Not Reported n/a = not applicable Author N Maffulli 161 Calf Squeeze Test Maffulli 161 (Thompson test/Simmonds squeeze test) Matles Test (increased Maffulli 105 passive ankle dorsiflexion) 15 v1.0 12.04.09 STUDY RESULTS Table 5. Sensitivity and specificity of Palpation, Calf Squeeze and Matles tests Test Sensitivity‡ (95% CI) Specificity‡ (95% CI) Maffulli 161 Palpation (presence of a gap) 0.73 (0.65, 0.80) 0.89 (0.72, 0.98) Maffulli 161 Calf Squeeze Test (Thompson test / Simmonds squeeze test) 0.96 (0.91, 0.99) 0.93 (0.76, 0.99) Maffulli 105 Matles Test (increased passive ankle dorsiflexion) 0.88 (0.79, 0.95) 0.86 (0.67, 0.96) Author N ‡ AAOS Calculation 16 v1.0 12.04.09 RECOMMENDATION 2 We are unable to recommend for or against the routine use of magnetic resonance imaging (MRI), ultrasound (ultrasonography), and radiograph (roentgengrams, x-rays) to confirm the diagnosis of acute Achilles tendon rupture. AAOS Strength of Recommendation – Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: A systematic review of the literature failed to identify adequate evidence to make a recommendation for or against the routine use of MRI, ultrasound, or radiographs to confirm the diagnosis of acute Achilles tendon rupture. There were no studies that address MRI or radiographs as confirmatory tests and there were only two level V studies16, 17 that addressed ultrasound. These two studies contain unreliable data and cannot be combined to provide adequate evidence. Supporting Evidence: No studies were identified to adequately answer this recommendation. To answer this recommendation the ideal study must investigate the incremental benefit added by one of the specified technologies (MRI, Ultrasound or plain radiograph). We found no studies that addressed MRI or plain radiographs as a confirmatory test. Studies were found that addressed ultrasound but they did not adequately address the recommendation using the necessary study design. The ideal study design required to address this recommendation compares two groups of patients. Group one patients undergo the Thompson test and then surgery (gold standard). Group two patients undergo the Thompson test and the test of interest (MRI, ultrasound, or plain radiographs) and then surgery. Sensitivity, specificity and likelihood ratios would be calculated and compared between groups to determine the incremental benefit added by the technology. No study included both of the groups. 17 v1.0 12.04.09 SUMMARY OF EVIDENCE Two Level V prospective studies that enrolled patients with complete Achilles tendon tears were found.16, 17 The studies used visual inspection at surgery as the gold standard for the diagnosis. One study had patients that underwent the Thompson test and then surgery. Patients in the second study underwent the Thompson test and Ultrasound and then surgery. The authors of the studies reported sensitivities and specificities or provided enough information for these parameters to be determined. EXCLUDED ARTICLES Table 6. Excluded Articles Author Title Exclusion Reason Fornage, 1986 Achilles tendon: US examination Less than 10 patients per group Haims, et al. 2000 Hartgerink, et al. 2001 Hollenberg, et al. 2000 Kabbani, et al. 1993 Kalebo, et al. 1992 Kayser, et al. 2005 Kuwada, 2008 Lehtinen, et al. 1994 Marshall, et al. 2002 Mathieson, et al. 1988 Paavola, et al. 1998 MR imaging of the Achilles tendon: overlap of findings in symptomatic and asymptomatic individuals Full- versus partial-thickness Achilles tendon tears: sonographic accuracy and characterization in 26 cases with surgical correlation Sonographic appearance of nonoperatively treated Achilles tendon ruptures Magnetic resonance imaging of tendon pathology about the foot and ankle. Part I. Achilles tendon Diagnostic value of ultrasonography in partial ruptures of the Achilles tendon Partial rupture of the proximal Achilles tendon: a differential diagnostic problem in ultrasound imaging Surgical correlation of preoperative MRI findings of trauma to tendons and ligaments of the foot and ankle Sonography of Achilles tendon correlated to operative findings Contrast-enhanced magic-angle MR imaging of the Achilles tendon Sonography of the Achilles tendon and adjacent bursae Ultrasonography in the differential diagnosis of Achilles tendon injuries and related disorders. A comparison between pre-operative ultrasonography and surgical findings 18 Does not investigate the diagnostic test Retrospective Chart Review Does not investigate the diagnostic test Commentary Chronic/neglected Achilles tendon rupture Partial Rupture Less than 10 patients per group Chronic/neglected Achilles tendon rupture Less than 10 patients per group Less than 10 patients per group Retrospective Chart Review v1.0 12.04.09 Author N Withdrawals explained Calf Squeeze Test Maffulli 161 (Thompson test/Simmonds squeeze test) Calf Squeeze Test (Thompson Margetic 88 test/Simmonds squeeze test) plus Ultrasound Uninterruptable/Intermediate test result(s) reported Index Test Clinical review bias avoided ● = Yes ○ = No X = Not Reported n/a = not applicable Reference Standard Open Repair X ○ ● ● ● ○ ● ● ● ● ○ ● ● ● Surgery X ○ ● ● ● ○ ● ● ● ○ ○ ● ● ○ 19 v1.0 12.04.09 Diagnostic review bias avoided Test review bias avoided Reference standard execution described Index test execution described Incorporation bias avoided Differential verification bias avoided Partial verification bias avoided Disease progression bias avoided Appropriate reference standard Selection criteria described Spectrum bias avoided STUDY QUALITY Table 7. Study Quality STUDY RESULTS Table 8. Sensitivity and Specificity Author N Maffulli 161 Margetic et. al. 88 Test Calf Squeeze Test (Thompson test / Simmonds squeeze test) Calf Squeeze Test (Thompson test / Simmonds squeeze test) plus ultrasound Sensitivity (95% CI) Specificity (95% CI) 0.96 (0.91, 0.99) 0.93 (0.76, 0.99) 0.91 (0.83, 0.96) 1.00 (0.16, 1.00) 20 v1.0 12.04.09 RECOMMENDATION 3 Non-operative treatment is an option for patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale: A systematic review of non-operative treatment compared to operative treatment of acute Achilles tendon ruptures identified four level II studies including all operative techniques.18-21 Three studies included standard open treatment and one included a minimally invasive technique. Increased complications were noted in the open operative group. When the outcomes of open and minimally invasive techniques were considered separately, the preliminary strength of recommendation was moderate. The group agreed that it was important to evaluate both functional outcomes and complications comparing non-operative and all operative treatment groups. When these heterogeneous groups were separated into non-operative and operative (including minimally invasive) treatments, the strength of recommendation was downgraded to limited. The functional outcomes were favorable in the operative group in 1 of 2 level II studies and the return to activity and sport in 1 of 3 level II studies. Only 1 of 4 studies demonstrated improvement in the rerupture rate in the operative group. The remainder of the studies demonstrated no difference between the groups. Higher complication rates, primarily due to impaired wound healing in the operative group, demonstrate the importance of awareness of surgical risk factors in the decision making of operative versus non-operative treatment (see Recommendation 6). With acceptable functional results and lower complication rates than operative treatment, non-operative treatment of acute Achilles tendon ruptures is an option in all patients, especially those with increased surgical risk factors. Supporting Evidence: To address this recommendation, we analyzed studies that made two different comparisons. Three level II studies compared patients treated non-operatively (with 21 v1.0 12.04.09 casting) to patients treated with open repair and one level II study compared casting to minimally invasive open repair.18-21 Two studies examined functional outcomes and both found non-significant results (Table 9). Based on AAOS calculations, one of these studies did have significant results at two, three, and six months measured by the Musculoskeletal Functional Assessment Index (MFAI) in which patients with operative treatment had better functional ability than those treated non-operatively; our results differ from the authors because a higher powered statistical test was used. Two studies reported no significant difference in the number of patients with pain (see Table 10). Three studies reported patients treated non-operatively did not significantly differ in the amount of time to return to work (see Table 11). Three studies examined return to sports and one reported significant results in favor of patients treated with operative repair (see Table 12). One study reported significantly less reruptures in patients treated operatively (see Table 13).The occurrence of extreme residual tendon lengthening, DVT, and “major” complications were not significantly different between patients treated operatively or non-operatively. Minor complications reported in the included studies were related to the surgical intervention and therefore occurred less in patients treated non-operatively (see Table 15). SUMMARY OF EVIDENCE Table 9. Operative vs. Cast – Function Duration (Months) Author Comparison Twaddle Open vs. Cast Cetti Open vs. Cast Outcome LOE N 2 weeks 2 ○ ●Op MFAI‡ II 42 Function II 111 3 6 12 ●Op ●Op ○ ○ ‡Musculoskeletal Functional Assessment Index ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 10. Operative vs. Cast – Pain Author Comparison Outcome LOE N Möller Open vs. Cast % w/ Pain‡ III 85 Minimally Invasive vs. Cast Pain (VAS) II 83 Metz Duration (Months) 2 3 12 ○ ○ ○ ○ ‡Level III evidence due to less than 80% of patients at follow-up ●Op: Statistically Significant in Favor of Operative Repair 22 v1.0 12.04.09 ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 11. Operative vs. Cast – Return to Work Author Comparison Outcome LOE Duration (Months) N 12 Cetti Open vs. Cast Sick Leave II 111 Möller Open vs. Cast Sick Leave II 112 24 ○ ○ Minimally Invasive vs. Return to Work II 78 Cast ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance ○ Metz Table 12. Operative vs. Cast - Return to Sport Author Comparison Outcome LOE Duration (Months) N 12 Cetti Open vs. Cast Möller Open vs. Cast Return to Sport Return to Sport II 111 II 112 24 ●Op Minimally Return to Invasive vs. II 69 Sport (%) Cast ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Metz ○ ○ Table 13. Operative vs. Cast - Rerupture Author Outcome LOE N Duration (Months) 12 Twaddle Rerupture II 42 ○ Cetti Rerupture II 111 ○ Möller Rerupture II 112 ●Op 23 v1.0 12.04.09 Metz Rerupture II ○ 83 ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 14. Operative vs. Cast - Satisfaction Author Comparison Outcome LOE Duration (Months) N 2 Möller Open Repair vs. Cast Satisfaction‡ (VAS) III 85 Minimally Invasive Satisfaction II 83 vs. Cast (VAS) ‡Level III evidence due to less than 80% of patients at follow-up ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Metz 3 ●Op ○ 6 12 24 ●Op ●Op ●Op ○ ○ Table 15. Operative vs. Cast – Complications Duration (Months) Adverse event/ Complication LOE Cetti Major Complications (not including rerupture) II 111 ○ Metz Total Complications II 83 ○ Möller Extreme Residual Tendon Lengthening II 112 ○ Möller DVT II 112 ○ Cetti Total - Minor Complications‡ II 111 ●Non-Op Metz Partial Sensibility II 83 ●Non-Op Cetti Disturbances of Sensibility II 111 ○ Möller Disturbance of Sensitivity II 112 ○ Metz Scar Adhesions II 83 ●Non-Op Möller Scar Adhesions II 112 ●Non-Op Author N 12 24 v1.0 12.04.09 Cetti Suture granuloma II 111 ○ Möller Superficial infection II 112 ○ ‡As defined by the author: “Differences between major/minor complications is that major complications give functional discomfort.” Minor Complications include: Scar adhesions, superficial infection, disturbances of sensibility, suture granuloma, delayed wound healing. ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Statistically Significant in Favor of Non-Operative treatment with Cast ○ No statistical significance Summary of Systematic Reviews Table 16. Systematic Review Summary Author Bhandari, M et al. 2002 Bhandari, M et al. 2002 Bhandari, M et al. 2002 Bhandari, M et al. 2002 Khan, RJK, et al. 2005 Lo, IKY, et al. 1997 Lo, IKY, et al. 1997 Lo, IKY, et al. 1997 Lynch, RM 2004 Conclusion "Deep venous thrombosis is more common after nonoperative treatment of Achilles tendon ruptures" (p. 195). "…The current group of randomized trials suggests a benefit to surgical repair of acute Achilles tendon ruptures in younger, active patients" (p. 199). "Pooled analysis of studies did not reveal any difference in the risk of minor complaints or return to normal function between surgical repair and conservatively treated groups" (p. 190). "Surgical treatment significantly reduces the risk of Achilles tendon re-ruptures, but increases the risk of infection, when compared with conservative therapy" (p. 190). "In conclusion, open operative treatment of acute Achilles tendon ruptures significantly reduces the risk of re-rupture compared with nonoperative treatment but has the drawback of a significantly higher risk of other complications, including wound infection" (p.2209). "Although operative treatment provides a reduced re-rupture rate over nonoperative treatment, the rate of moderate and mild complications in operative treatment is 20 times greater" (p. 211). "Presently, we favor non-operative treatment in patients with poor healing potential (i.e., smokers, diabetics, and patients with peripheral vascular disease)" (p. 211). "For healthy active individuals, we offer both forms of treatment, providing the patients with the estimates of treatment success and complication rates" (p. 211). "Surgical treatment is preferable to non-surgical treatment, produces better functional outcomes, and therefore appears to be the treatment of choice" (p. 156). 25 v1.0 12.04.09 Author Lynch, RM 2004 Lynch, RM 2004 Lynch, RM 2004 Lynch, RM 2004 Conclusion "The incidence of re-rupture following non-surgical treatment is significantly higher than for surgical treatment" (p. 156). "The number of patients that need to be treated surgically to prevent one re-rupture if these patients were treated nonsurgically is 5 (3-13, 95% confidence intervals)" (p.156). "The incidence of minor complications following surgical treatment is large, but these do not appear to affect functional outcome" (p. 156). "Non-surgical treatment should be reserved for patients who refuse or who are unfit for operative repair" (p. 156). EXCLUDED ARTICLES Table 17. Excluded Articles Author Title Exclusion Reason Doral, et al. 2009 Neumayer, et al. 2009 Ebinesan, et al. 2008 Lorkowski, et al. 2007 Kotnis, et al. 2006 van, et al. 2004 Percutaneous suturing of the ruptured Achilles tendon with endoscopic control Not best available evidence - not comparative A new conservative-dynamic treatment for the acute ruptured Achilles tendon Not best available evidence - not comparative Conservative, open or percutaneous repair for acute rupture of the Achilles tendon Not best available evidence retrospective comparative Evaluation of long term therapy outcomes for Achilles tendon ruptures Combines operative and nonoperative patients Weber, et al. 2003 Follak, et al. 2002 Moller, et al. 2002 Rumian, et al. 2001 Horstmann, et al. Dynamic ultrasound as a selection tool for reducing Achilles tendon re-ruptures Results of surgical versus non-surgical treatment of Achilles tendon rupture Non-operative treatment of acute rupture of the Achilles tendon. results of a new protocol and comparison with operative treatment The utility of gait analysis in the rehabilitation of patients after surgical treatment of Achilles tendon rupture Calf muscle function after Achilles tendon rupture. A prospective, randomised study comparing surgical and non-surgical treatment Not best available evidence Not best available evidence Not best available evidence retrospective comparative Not best available evidence - not comparative Duplicate - Data reported in prior study Surgical repair of the Achilles tendon. The lateral approach Not best available evidence - not comparative Isokinetic strength and strength endurance of the lower limb musculature ten years after Not best available evidence - not comparative 26 v1.0 12.04.09 Author Title 2000 Achilles tendon repair Rowley, et al. 1982 Rupture of the Achilles tendon treated by a simple operative procedure Inglis, et al. 1976 Nistor, et al. 1981 Jacobs, et al. 1978 Exclusion Reason Ruptures of the tendo achillis. An objective assessment of surgical and non-surgical treatment Surgical and non-surgical treatment of Achilles Tendon rupture. A prospective randomized study No patient oriented outcome Less than 10 patients per group A new conservative-dynamic treatment for the acute ruptured Achilles tendon Not best available evidence Combines acute and neglected/chronic Achilles tendon tear patients Stochastic Randomization Allocation Concealment Patients Blinded Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry STUDY QUALITY Table 18. Study Quality Level II ● ● ○ ● ● × Level II ● ● ○ ● ● × Level II ● ● ○ ● ● ● Level II ● ● ○ ● ● ● Level II ● ● ○ ● ● ● Level II ● ● ○ ● ● ● Level III ● ● ○ ● ○ ● Level II × × ○ ● ● ● Level II Level II × × × × ○ ○ ● ● ● ● ● ● ● = Yes ○ = No × = Not Reported Author Outcome N Twaddle MFAI 42 Twaddle Re-rupture 42 Moller Re-rupture 112 Moller Return to work Quality of Life (VAS) Treatment Results (VAS) 112 Moller Moller Moller Pain Cetti Return to Work Cetti Return to Sports Cetti Hospitalization 112 112 85 111 111 111 Treatment(s) Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. 27 Level of Evidence v1.0 12.04.09 Stochastic Randomization Allocation Concealment Patients Blinded Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry Level II ○ ○ × × ● × Level II ● ● ○ ● ● ● Level II ● ● ○ ● ● ● Level II ● ● ○ ● ● × Level II ● ● ○ ● ● × ● = Yes ○ = No × = Not Reported Author Outcome N Metz Re-rupture 83 Metz Return to work 83 Metz Return to sport 83 Metz Pain- VAS Satisfaction VAS 83 Metz 83 Level of Evidence Treatment(s) Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast Operative vs. Cast STUDY RESULTS Table 19. Open vs. Cast - Function Durati on Open Repair mean (SD) % mean (SD) % 42.4 (2.7)‡ 43 (2.7)‡ p = 0.48‡ 23.7 (2.6)‡ 27.6 (3.4)‡ p = 0.002‡ 15.2 (2.1)‡ 17 (2.6)‡ p = 0.02‡ 7.8 (2.1)‡ 10.4 (2.2)‡ p = 0.004‡ 3.4 (1.7)‡ 4.2 (1.7)‡ p = 0.14‡ Cast Author Comparison Outcome LOE N Twaddle Open vs. Cast MFAI II 42 Twaddle Open vs. Cast MFAI II 42 Twaddle Open vs. Cast MFAI II 42 Twaddle Open vs. Cast MFAI II 42 Twaddle Open vs. Cast MFAI II 42 II 111 12 months 5.4% 3.6% NS II 111 12 months 12.5% 18.2% NS II 111 12 months 8.9% 9.1% NS Cetti Open vs. Cast Cetti Open vs. Cast Cetti Open vs. Cast Function Abnormal Gait Function – Abnormal Run Function Abnormal Toe Stand 28 2 weeks 2 months 3 months 6 months 12 months v1.0 12.04.09 Results ‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. Table 20. Cast vs. Open Repair - Pain Author Möller Möller Möller Comparison Outcome Open vs. Cast Open vs. Cast Pain None Pain Moderate Pain During Walking Open vs. Cast Minimally Invasive vs. Cast Minimally Metz Invasive vs. Cast Minimally Metz Invasive vs. Cast ‡ AAOS Calculation Metz Duration Open Repair mean (SD) % Minimally Invasive Cast mean (SD) % mean (SD) % 92% n/a 88% p = .69‡ 6% n/a 3% p = .55‡ LOE N III 85 III 85 III 85 12 months 2% n/a 9% p = .129‡ Pain (VAS)‡ II 83 2 months n/a 1.80 (1.40)‡ 1.56 (1.25)‡ p= 0.20‡ Pain (VAS) II 83 3 months n/a 1.53 (1.71)‡ 1.80 (1.40)‡ p = 0.78‡ Pain (VAS) II 83 12 months n/a 0.40 (0.93)‡ 0.78(1.40)‡ p= 0.92‡ 12 months 12 months NS: No statistical significance; authors do not report p-value. n/a: not applicable 29 v1.0 12.04.09 Results Table 21. Operative vs. Cast - Return to Work Author Comparison Outcome LOE N Open Repair Minimally Invasive Cast mean (SD) mean (SD) mean (SD) 43.4 (15.05) n/a 56 (25.2) NS 54.9 (47.9) n/a 73.4 (56.5) p= 0.06 Results Duration 12 months 24 months Cetti Open vs. Cast Return to Work (days) II 111 Möller Open vs. Cast Sick Leave (days) II 111 Möller Open vs. Cast Return to heavy work (days) II 24 24 months 102.2 (52.7) n/a 108.1(34.7) NS Möller Open vs. Cast Return to light work (days) II 54 24 months 35.7 (38) n/a 67.2 (65.9) p= 0.03 Möller Open vs. Cast Return to Work – Sedentary (days) II 34 24 months 30.8 (36.5) n/a 33.2 (54.7) NS Metz Minimally Invasive vs. Cast Return to Work (days) II 78 12 months n/a 59 (82) 108 (115) p< 0.05 ‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. n/a: not applicable 30 v1.0 12.04.09 Table 22. Operative vs. Cast - Return to Sport Author Comparison Cetti Open vs. Cast Cetti Open vs. Cast Möller Open vs. Cast Cetti Open vs. Cast Cetti Open vs. Cast Möller Open vs. Cast Outcome N II 111 12 months 79% n/a 64% p= .21‡ II 111 12 months 57% n/a 29% p =.005 II 112 12 months 54% n/a 54% NS II 111 12 months 21% n/a 35% NS II 111 12 months 14% n/a 22% NS II 112 12 months 16% n/a 14% p= .620‡ II 69 12 months n/a 67% 81% p= 0.16 Return to SportsTotal Return to Sport Same Level Return to Sport Same Level Return to Sport Diminished Return to Sport Stopped Return to Sport Stopped Minimally Invasive vs. Cast ‡ AAOS Calculation Metz Open Minimally Cast Duration Repair Invasive Results % % % LOE Return to Sport NS: No statistical significance; authors do not report p-value. n/a: not applicable Table 23. Operative vs. Cast - Rerupture Author Complication LOE N Cetti Rerupture II 111 Möller Rerupture II 112 Twaddle Rerupture II 42 Metz Rerupture II 83 Cetti Second Rerupture II 111 Duration 12 months 12 months 6 months 12 months 12 months Open Repair Minimally Invasive Cast % % % 5.4% n/a 12.7% p = .167‡ 1.7% n/a 20.8% p = < .001 10.0% n/a 4.5% p = .49‡ n/a 7.1% 12.2% p = 0.44‡ 0.0% n/a 1.8% p = .154‡ Results ‡ AAOS Calculation n/a: not applicable 31 v1.0 12.04.09 Table 24 Cast vs. Open - Complications Author Metz Cetti Metz Complications Total Complications Major Complications (not including rerupture) Total Complications Other Than Rerupture LOE N % 28.6% 48.8% p = 0.06 II 111 12 months 9.0% n/a 16.3% NS II 83 12 months n/a 21.4% 36.6% p = 0.13 n/a 7.1% 2.4% p = 0.30‡ 3.6% n/a 0% p = 0.05 n/a 0 0.0% NS 1.8% n/a 0% p = 0.158‡ 12.5% n/a 1.8% p = 0.017‡ 1.7% n/a 0% p = 0.16‡ n/a 9.5% 0.0% p = 0.01‡ n/a 0.0% 2.4% p = 0.15‡ 0.0% n/a 1.9% p = 0.14‡ 0.0% n/a 0% NS Cetti Deep Infection II 111 II 83 II 111 II 111 II 112 Möller % n/a 83 Cetti % 12 months II Cetti Results 83 Sural Nerve Injury Deep Wound Infection Delayed Wound Healing Disturbances of Sensibility Disturbance of Sensitivity Cast II Metz Metz Duration Open Minimally Repair Invasive 12 months 12 months 12 months 12 months 12 months 24 months 12 months 12 months 24 months 12 months Metz Partial Sensibility II 83 Metz DVT - lower leg II 83 Möller DVT II 112 II 112 II 111 12 months 0.0% n/a 1.8% p = 0.15‡ II 112 24 months 0.0% n/a 1.9% p = 0.14‡ II 111 26.8% n/a 5.4% p = 0.004 II 83 n/a 4.8% 31.7% p = .001‡ 10.7% n/a 3.6% p = 0.136‡ n/a 7.1% 0.0% p = 0.01‡ Cetti Cetti Möller Cetti Metz Necrosis of the Skin Extreme Residual Tendon Lengthening Extreme Residual Tendon Lengthening Total - Minor Complications Skin Related Complications Cetti Scar Adhesions II 111 Metz Scar Adhesions II 83 12 months 12 months 12 months 12 months 32 v1.0 12.04.09 Author Complications LOE N Möller Scar Adhesions II 112 Cetti Suture Granuloma II 111 II 112 Superficial Infection ‡ AAOS Calculation Möller Duration 24 months 12 months 24 months Open Minimally Repair Invasive Cast Results % % % 13.6% n/a 0% p = <.001‡ 1.8% n/a 0% p = 0.158‡ 1.7% n/a 0% p = 0.16‡ NS: No statistical significance; authors do not report p-value. n/a: not applicable 33 v1.0 12.04.09 RECOMMENDATION 4 For patients treated non-operatively, we are unable to recommend for or against the use of immediate functional bracing for patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: Non-operative treatment for Achilles tendon ruptures was evaluated by comparing the use of immediate functional bracing or a combination of casting with functional bracing (for a period of 0-12 weeks) to casting alone. One level II and one level IV comparative study were analyzed. The only outcome that could be adequately determined in these studies was rerupture rate which was not significantly different. 22, 22 Functional outcomes of the functional bracing group were analyzed with three studies (level IV and V) and no case series of cast treatment alone was identified. 23-25 With the lack of functional data demonstrating improved outcomes with functional bracing and the lack of demonstrable difference in rerupture rates, we are unable to recommend for or against the use of immediate functional bracing for patients treated non-operatively for acute Achilles tendon rupture. Supporting Evidence: We analyzed one level II and one level IV study that compared patients treated with cast plus a functional brace vs. patients treated with a cast only. 26 22 We reported the rerupture rates of both comparative studies but other outcomes were considered due to the reliability of the evidence reported in both studies (See Methods Section – Outcomes considered). We then examined three studies (Level IV and V) that reported results for patients treated with functional bracing. 23-25 In both comparative studies, rerupture rates did not significantly differ between patients treated with cast plus orthosis vs. cast (see Table 25). See Table 36 for case series rerupture rates. Seventy-eight percent of patients treated with a functional brace had no pain, 55% reported no stiffness, 56% had no weakness, 98% of patients returned to full level of employment and 37% returned to the same level of sports at 2.9 years. The average time to return to work was 7 days (range 21 – 52) (see Table 26). 34 v1.0 12.04.09 One study reported 2% of patients had a pulmonary embolism and another study reported 1% of patients with a DVT and “temporary drop foot” (see Table 35). SUMMARY OF EVIDENCE Table 25. Cast + Functional Brace vs. Cast - Rerupture Cast + orthosis (%) Results Author Outcome LOE N Duration Cast (%) Saleh, et al. 1992 Rerupture II 31 12 months 6% 7% p=.96‡ Ingvar, et al. 2005 Rerupture ‡ AAOS calculation IV 194 4 years 7% 10% p=.51‡ Table 26. Summary of Results - Case Series Author Wallace Outcome Pain - none LOE IV N 140 Duration 2.9 years Results (%) 78% Wallace Stiffness – none IV 140 2.9 years 55% Wallace Weakness – none IV 140 2.9 years 56% Wallace Return to Full Preinjury Level of Employment IV 122 2.9 years 98% Wallace, et al. 2004 Return to Sports - same or better level IV 101 2.9 years 37% Table 27. Summary of Systematic Reviews Author Lynch, RM 2004 Conclusion "Early functional mobilisation is more acceptable to patients than plaster cast immobilisation and results in improved functional outcomes" (p. 156). 35 v1.0 12.04.09 Table 28. Functional Bracing – Satisfaction (VAS) Author Outcome LOE N Duration Results (mean ± SD) Neumayer, et al. 2009 Satisfaction (VAS) IV 46 5 years 8.1 ± 2 Table 29. Functional Bracing - Satisfaction (%) Author Outcome LOE N Duration Results (%) Wallace, et al. 2004 Satisfaction – very satisfied IV 140 2.9 years 83% IV 140 2.9 years 15% IV 140 2.9 years 1% IV 140 2.9 years 1% Wallace, et al. 2004 Wallace, et al. 2004 Wallace, et al. 2004 Satisfaction – satisfied with minor reservations Satisfaction – satisfied with major reservations Satisfaction – dissatisfied Table 30. Functional Bracing - Pain Author Outcome LOE N Duration Results (%) Wallace, et al. 2004 Pain - none IV 140 2.9 years 78% Wallace, et al. 2004 Pain - mild IV 140 2.9 years 13% Wallace, et al. 2004 Pain - moderate IV 140 2.9 years 8% Wallace, et al. 2004 Pain – severe IV 140 2.9 years 1% Table 31. Functional Bracing - Function Author Outcome LOE N Duration Results (%) Wallace, et al. 2004 Stiffness – none IV 140 2.9 years 55% 36 v1.0 12.04.09 Wallace, et al. 2004 Stiffness – mild IV 140 2.9 years 41% Wallace, et al. 2004 Stiffness – moderate IV 140 2.9 years 3% Wallace, et al. 2004 Stiffness – severe IV 140 2.9 years 1% Table 32. Functional Bracing - Strength Author Outcome LOE N Duration Results (%) Wallace, et al. 2004 Weakness – none IV 140 2.9 years 56% Wallace, et al. 2004 Weakness - mild IV 140 2.9 years 33% Wallace, et al. 2004 Weakness moderate IV 140 2.9 years 10% Wallace, et al. 2004 Weakness -severe IV 140 2.9 years 1% Table 33. Functional Bracing - Return to Work and Sports Author Outcome McComis, et al. 1997 Return to Full Preinjury Level of Employment Return to Sports same or better level Return to Sports diminished or none Return to Sports same level McComis, et al. 1997 Return to Sports diminished Wallace, et al. 2004 Wallace, et al. 2004 Wallace, et al. 2004 LOE N Duration Results (%) IV 122 2.9 years 98% IV 101 2.9 years 37% IV 101 2.9 years 63% V 15 26 weeks 67% V 15 26 weeks 33% Table 34. Functional Bracing - Return to Work and Sports (days) Author Outcome LOE N 37 Results (mean) v1.0 12.04.09 Wallace, et al. 2004 Time to Return to Work IV 122 McComis, et al. 1997 Time to Return to Work V 15 Wallace, et al. 2004 Time to Return to Sports IV 101 7 days (max: 52 days) 4 days (max: 3 weeks) 8 weeks (range 2 weeks - 6 months) Table 35. Functional Bracing - Complications N Duration (%) Cast + orthosis (%) IV 57 12 months n/a 2% n/a DVT IV 140 2.9 years (0.4-8.2) n/a 1% n/a Temporary Drop foot IV 140 2.9 years (0.4-8.2) n/a 1% n/a Cast Author Outcome Neumayer, et al. 2009 Pulmonary embolism Wallace, et al. 2004 Wallace, et al. 2004 LOE Results n/a: not applicable Table 36. Functional Bracing - Rerupture Author Outcome LOE N Duration Cast (%) Cast + orthosis (%) Results Neumayer, et al. 2009 Complete rerupture IV 57 12 months n/a 9% n/a Wallace, et al. 2004 Complete rerupture IV 140 2.9 years (0.4-8.2) n/a 2% n/a Neumayer, et al. 2009 Partial rerupture IV 57 12 months n/a 4% n/a Wallace, et al. 2004 Partial rerupture IV 140 2.9 years (0.4-8.2) n/a 4% n/a n/a: not applicable EXCLUDED ARTICLES Table 37. Functional Bracing - Excluded Studies Author Edna TH; Fruensgaard S, et al. Title Non-operative treatment of Achilles tendon ruptures Conservative treatment for acute rupture of the Achilles tendon 38 Exclusion Reason case series cast only casting only v1.0 12.04.09 Author Title Long-term results after functional non-operative treatment of Achilles tendon rupture Hufner TM, et al. Exclusion Reason cast only case series Inglis AE, et al. Ruptures of the tendo achillis. An objective assessment of surgical and non-surgical treatment Less than 10 patients per arm Josey RA, et al. Immediate, full weight bearing cast treatment of acute Achilles tendon ruptures: a long-term follow-up study cast only case series Keller J, et al Lea RB; Smith L; Closed treatment of Achilles tendon rupture Non-surgical treatment of tendo achillis rupture case series cast only casting only Lildholdt T, et al Conservative treatment to Achilles tendon rupture. A follow-up study of 14 cases cast only case series Nistor L; Conservative treatment of fresh subcutaneous rupture of the Achilles tendon casting only case series Pendleton H, et al. Residual functional problems after non-operative treatment of Achilles tendon rupture cast only case series The treatment of total ruptures of the Achilles tendon by plaster immobilisation Dynamised cast management of Achilles tendon ruptures Persson A, et al. Roberts CP, et al cast only case series retrospective case series Outcome N Treatment(s) Level of Evidence Allocation Concealment Patients Blinded Author Stochastic Randomization Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry STUDY QUALITY Table 38. Study Quality - Randomized Control Trials Saleh, et al. 1992 Rerupture 31 Cast vs. Cast + Orthosis Level II × × ○ ○ ● ● ● = Yes ○ = No × = Not Reported ● = Yes ○ = No × = Not Reported Completion rate - less than 20% difference All groups between concurrently groups groups All treated All groups same receive evaluated treatment groups Allusing outcome samehave approximately measures equal followFollow Up up times center Same 80% or more for experimental Similar and control performance group data on outcome Patient at baseline characteristics comparable at baseline Table 39. Study Quality - Non-Randomized Comparative Study 39 v1.0 12.04.09 Author Ingvar, et al. 2005 Outcome N Treatment(s) Level of Evidence Re-rupture 194 Cast vs. Cast + Orthosis Level IV × ○ ● ● ● × ● ● × Consecutive enrollment of patients Follow Up - 80% or more All patients evaluated using same outcome measures Outcome N Treatment(s) Level of Evidence All patients receive same treatment All patients have approximately equal follow-up times Table 40. Study Quality - Case Series Satisfaction (VAS) 46 Cast + Orthosis Level IV ● ● ● ● ● Satisfaction 140 Cast + Orthosis Level IV ● ● ● ● ● Pain 140 Cast + Orthosis Level IV ● ● ● ● ● Stiffness 140 Cast + Orthosis Level IV ● ● ● ● ● 140 Cast + Orthosis Level IV ● ● ● ● ● Wallace, et al. 2004 Weakness Return to Full Preinjury Level of Employment 122 Cast + Orthosis Level IV ● ● ● ● ● Wallace, et al. 2004 Return to Sports same or better level 101 Cast + Orthosis Level IV ● ● ● ● ● Wallace, et al. 2004 McComis, et al. 1997 McComis, et al. 1997 Return to Sports diminished or none Return to Sports same level Return to Sports diminished 101 Cast + Orthosis Level IV ● ● ● ● ● 15 Cast + Orthosis Level V ● ○ ● ● ● 15 Cast + Orthosis Level V ● ○ ● ● ● ● = Yes ○ = No × = Not Reported Author Neumayer, et al. 2009 Wallace, et al. 2004 Wallace, et al. 2004 Wallace, et al. 2004 Wallace, et al. 2004 40 v1.0 12.04.09 Consecutive enrollment of patients Follow Up - 80% or more All patients evaluated using same outcome measures N Treatment(s) Level of Evidence All patients receive same treatment All patients have approximately equal follow-up times 122 Cast + Orthosis Level IV ● ● ● ● ● 15 Cast + Orthosis Level V ● ○ ● ● ● 140 Cast + Orthosis Level IV ● ● ● ● ● 57 Cast + Orthosis Level IV ● ● ● ● ● 140 Cast + Orthosis Level IV ● ● ● ● ● Partial rerupture 57 Cast + Orthosis Level IV ● ● ● ● ● Partial rerupture Pulmonary embolism 140 Cast + Orthosis Level IV ● ● ● ● ● 57 Cast + Orthosis Level IV ● ● ● ● ● DVT Temporary Drop foot 140 Cast + Orthosis Level IV ● ● ● ● ● 140 Cast + Orthosis Level IV ● ● ● ● ● ● = Yes ○ = No × = Not Reported Author Outcome Wallace, et al. 2004 McComis, et al. 1997 Wallace, et al. 2004 Neumayer, et al. 2009 Wallace, et al. 2004 Neumayer, et al. 2009 Wallace, et al. 2004 Neumayer, et al. 2009 Wallace, et al. 2004 Wallace, et al. 2004 Time to Return to Work Time to Return to Work Time to Return to Sports Complete rerupture Complete rerupture 41 v1.0 12.04.09 RECOMMENDATION 5 Operative treatment is an option in patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale: To answer this recommendation, we reviewed studies addressing the efficacy of operative treatment. A systematic review of the literature included eight studies20, 19, 27, 28, 29, 30,31, 32 that addressed the efficacy of open repair and six studies33, 29, 34, 21, 27, 31, addressing the efficacy of minimally invasive techniques. This systematic review addressed only the efficacy of operative treatment and therefore did not consider the comparisons made in the studies. Please refer to Recommendation 3 and its rationale for a comparison of nonoperative and operative treatment of acute Achilles tendon ruptures. In addition, relevant comparative information about operative techniques can be found in Recommendation 8 and its rationale. A systematic review of the literature included eight studies20, 19, 27, 28, 29, 30,31, 32 that addressed the efficacy of open repair and six studies33, 29, 34, 21, 27, 31 addressing the efficacy of minimally invasive techniques. By six months the return to activity ranged from 73% to 100% after operative treatment (see Table 42 through Table 58). After twelve months, 92% of patients reported they had no pain (see Table 48). All studies relevant to this Recommendation were Level IV (see Table 60) because this is non comparative data. Supporting Evidence: To determine the efficacy of open repair and/or minimally invasive repair we need a study with preoperative and postoperative data. However, the data we identified only provides postoperative measures and is therefore unreliable. We have tabled the postoperative data from eight studies20, 19, 27, 28, 29, 30,31,32 that address efficacy of open repair and six studies 33, 29, 34, 21, 27, 31 that address minimally invasive techniques. Table 42 through Table 58 demonstrate the wide variety of patient-oriented outcome measures and duration to follow-up used to evaluate patients receiving operative treatment for Achilles tendon rupture. The inconsistency of these outcome measures makes comparisons between studies difficult. Because the body of evidence is limited, it does not allow for additional statistical analysis. 42 v1.0 12.04.09 Please see Recommendation 7 for results of operative treatment comparisons. 43 v1.0 12.04.09 SUMMARY OF EVIDENCE Table 41. Open Repair – All Outcomes Outcome Result (Efficacy) Time until Return to Work ? Time until Return to Stair Climbing ? Time until Return to Walking ? Time until Return to Sports ? Return to work (%) ? Return to ADL (%) ? Return to Final Functional Activities (%) ? Pain (%) ? Function- Abnormal ankle movement (%) ? Abnormal Run (%) ? Abnormal toe stand (%) ? Satisfaction (%) ? Table 42. Open Repair - Return to work Author LOE N Outcome Mean time Mean (SD) Moller, et al. 2001 IV 59 Return to work (days) 54.9 (nr) Cetti, et al. 1993 IV 56 Return to work (weeks) 6.2 (SD 2.15) Moller, et al. 2001 IV 59 Return to heavy work (days) 102.2 (nr) Moller, et al. 2001 IV 59 Return to sedentary work (days) 30.8 (nr) Moller, et al. 2001 IV 59 Return to light, mobile work (days) 35.7 (nr) nr: not reported 44 v1.0 12.04.09 Table 43. Open Repair - Activities of daily living Author Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 LOE N IV 53 IV 53 Uchiyama, et al. 2007 IV 84 Uchiyama, et al. 2007 IV 84 Outcome Return to Normal Stair Climbing (weeks) Return to Normal Walking (weeks) Return to same level of sports (months) (high level athletes) Return to jogging (weeks) Mean time Mean (SD)/(range) 19 (3.5)‡ 17 (3)‡ 5 (17-26 weeks) 12.3 (range 821) ‡AAOS Calculation Table 44. Open Repair- Mean time until return to athletic activity Author LOE N Uchiyama, et al. 2007 IV 84 Uchiyama, et al. 2007 IV 84 Outcome Return to same level of sports (months) (high level athletes) Return to jogging (weeks) 45 Mean time Mean (range) 5 (17-26 weeks) 12.3 (8-21) v1.0 12.04.09 Table 45. Open Repair- Percent of patients able to return to activities of daily living Follow% of up Patients 2 Lim, et al. 2001 IV 33 Return to ADL 6% months 3 Lim, et al. 2001 IV 33 Return to ADL 85% months 6 Lim, et al. 2001 IV 33 Return to ADL 100% months Return to final functional 3 Lim, et al. 2001 IV 33 36% activity‡ months Return to final functional 6 Lim, et al. 2001 IV 33 64% activity‡ months ‡ Final functional activity defined as “patient is unhindered in all his or her activities apart from active sports” Author LOE N Outcome Table 46. Open Repair- Percent of patients able to return to work Author LOE N Outcome Followup % of Patients Moller, et al. 2001 IV 59 Return to work (days) nr 100% Moller, et al. 2001 IV 59 Return to sedentary work (days) nr 22% Moller, et al. 2001 IV 59 Return to light, mobile work (days) nr 54% Moller, et al. 2001 IV 59 Return to heavy work (days) nr 24% Nr: not reported Table 47. Open Repair- Percent of patients able to return to sports Author LOE N Outcome Followup % of Patients Coutts, et al 2002 IV 22 Return to pre-injury sporting level nr 91% Moller, et al. 2001 IV 47 Return to sports - same level Cetti, et al. 1993 IV 52 Return to sports - same level Lim, et al. 2001 IV 33 Lim, et al. 2001 IV 33 Moller, et al. 2001 IV 47 Return to active sporting/outdoor activities Return to active sporting/outdoor activities Return to sports - stopped 46 12 months 12 months 3 months 6 months 12 months 54% 62% 9% 48% 16% v1.0 12.04.09 Author LOE N Outcome Cetti, et al. 1993 IV 52 Return to sports - stopped Cetti, et al. 1993 IV 52 Return to sports - diminished level Followup 12 months 12 months % of Patients 15% 23% Table 48: Open Repair- Percent of patients with pain Author LOE N Outcome Follow-up % of Patients Aktas, et al. 2007 IV 30 Pain - Mild w/ maximal exertion 6 months 14% Aktas, et al. 2007 IV 30 Pain - Absent 6 months 86% Moller, et al. 2001 IV 52 Pain-during walking 12 months 2% Moller, et al. 2001 IV 52 Pain-moderate 12 months 6% Moller, et al. 2001 IV 52 Pain-none 12 months 92% Aktas, et al. 2009 IV 23 Pain- mild during exertion 22 months 13% Table 49. Open Repair- Percent of patients able to complete functional activities Author LOE N Cetti, et al. 1993 IV 56 Cetti, et al. 1993 IV 56 Cetti, et al. 1993 IV 56 Cetti, et al. 1993 IV Cetti, et al. 1993 Outcome Function-Abnormal ankle movement Function-Abnormal ankle movement Follow-up % of Patients 4 months 52% 12 months 18% Function-Abnormal gait 4 months 27% 56 Function-Abnormal gait 12 months 5% IV 56 Function-Abnormal run 4 months 52% Cetti, et al. 1993 IV 56 Function-Abnormal run 12 months 13% Cetti, et al. 1993 IV 56 Function-Abnormal toe stand 4 months 21% Cetti, et al. 1993 IV 56 Function-Abnormal toe stand 12 months 9% Table 50. Open Repair- Percent of patients with excellent satisfaction Author Lim, et al. 2001 LOE N IV 33 Outcome Satisfaction - Excellent 47 Follow-up % of Patients 6 months 42% v1.0 12.04.09 Table 51. Minimally Invasive Repair- All outcomes Outcome Result (Efficacy) Return to Work (%) ? Return to Stair Climbing (%) ? Return to Walking (%) ? Return to Sports (%) ? Return to work (%) ? Return to ADL (%) ? Return to Final Functional Activities (%) ? Satisfaction (%) ? Function- Abnormal ankle movement (%) ? Return to same level of activity (%) ? Able to walk without limitations (%) ? Return to sports (%) ? Pain (%) ? Table 52. Minimally Invasive Repair- Percent of Patients able to return to activity Author ES Ng, et al. 2007 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Chillemi, et al. 2002 LOE N Treatment Outcome Follow-up % of Patients IV 25 percutaneous Return to activity same level 65.5 months 96% IV 33 percutaneous Return to ADL 2 months 6% IV 33 percutaneous Return to ADL 3 months 76% IV 33 percutaneous Return to ADL 6 months 100% IV 33 percutaneous 3 months 27% IV 33 percutaneous 6 months 73% IV 38 percutaneous 6 months 100% Return to final functional activity Return to final functional activity Able to walk without limitation 48 v1.0 12.04.09 Table 53. Minimally Invasive Repair - Percent of patients able to return to sports Author LOE N Treatment Lim, et al. 2001 IV 33 percutaneous Lim, et al. 2001 IV 33 percutaneous Chillemi, et al. 2002 IV 14 percutaneous Outcome Return to active sporting/outdoor activities Return to active sporting/outdoor activities Return to sports activity (frequent participant 2-3 times per week) Follow-up % of Patients 3 months 0% 6 months 67% nr 57% nr: not reported Table 54. Minimally Invasive Repair - Satisfaction Author LOE Lim, et al. 2001 IV Treatment N Outcome Follow-up % percutaneous 33 Satisfaction Excellent 6 months 52% Table 55. Minimally Invasive Repair - Mean time until return to activity Author LOE Metz, et al. IV 2008 Bhattacharyya, IV et al. 2009 Bhattacharyya, IV et al. 2009 Treatment N Outcome Mean Time (Days) Mean (SD) minimally-invasive 40 Return to work 59 (82) minimally-invasive 53 12.5 (3)‡ minimally-invasive 53 Return to Normal Walking (weeks) Return to Normal Stair Climbing (weeks) 14 (3)‡ ‡= AAOS Calculation Table 56. Minimally Invasive Repair-Percent of patients able to return to sports Author LOE Metz, et al. IV 2008 Metz, et al. IV 2008 Metz, et al. IV 2008 Metz, et al. IV 2008 nr: not reported Treatment N Outcome Follow-up % of Patients minimally-invasive 36 Return to sports 12 months 67% minimally-invasive 36 Change sports 12 months 11% minimally-invasive 36 Stop sports 12 months 22% minimally-invasive 40 Return to work nr 98% 49 v1.0 12.04.09 Table 57. Minimally Invasive Repair-Percent of patients able to return to work Author LOE Metz, et al. IV 2008 nr: not reported Treatment N Outcome Follow-up % of Patients minimally-invasive 40 Return to work nr 98% Follow-up % of Patients 22 months 4.5% Table 58. Minimally Invasive Repair-Pain Author Aktas, et al.2009 LOE IV Treatment N minimally-invasive 23 Outcome Percent of patient with mild pain during exertion EXCLUDED ARTICLES Table 59. Excluded Articles Author Title Leppilahti J;Forsman K;Puranen J;Orava S; Outcome and prognostic factors of Achilles rupture repair using a new scoring method Chiodo CP;Wilson MG; Current concepts review: acute ruptures of the Achilles tendon Maffulli N;Tallon C;Wong J;Lim KP;Bleakney R; Nonoperative treatment of acute rupture of the Achilles tendon: results of a new protocol and comparison with operative treatment Early weightbearing and ankle mobilization after open repair of acute midsubstance tears of the Achilles tendon Halasi T;Tallay A;Berkes I; Percutaneous Achilles tendon repair with and without endoscopic control Costa ML;Shepstone L;Darrah C;Marshall T;Donell ST; Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study Maffulli N;Tallon C;Wong J;Peng LK;Bleakney R; No adverse effect of early weight bearing following open repair of acute tears of the Achilles tendon van der Linden-van der Zwaag HM;Nelissen RG;Sintenie JB; Results of surgical versus non-surgical treatment of Achilles tendon rupture Weber M;Niemann M;Lanz R;Muller T; 50 Exclusion Reason Not best available evidence Not best available evidence Retrospective Not Relevant Retrospective Not best available evidence Not relevantlooks at effect of weight bearing following surgery Not best available evidence v1.0 12.04.09 Author Title Steele GJ;Harter RA;Ting AJ; Comparison of functional ability following percutaneous and open surgical repairs of acutely ruptured Achilles tendons Cretnik A;Kosanovic M;Smrkolj V; Percutaneous versus open repair of the ruptured Achilles tendon: a comparative study Goren D;Ayalon M;Nyska M; Isokinetic strength and endurance after percutaneous and open surgical repair of Achilles tendon ruptures Wagnon R;Akayi M; Mortensen HM;Skov O;Jensen PE; The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures: a functional and MRI assessment Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. A prospective, randomized clinical and radiographic study Exclusion Reason No patientoriented outcome Not best available evidence No patient oriented outcome Not best available evidence Not best available evidence Hufner TM;Brandes DB;Thermann H;Richter M;Knobloch K;Krettek C; Long-term results after functional nonoperative treatment of Achilles tendon rupture Not best available evidence Kauranen K;Kangas J;Leppilahti J; Recovering motor performance of the foot after Achilles rupture repair: a randomized clinical study about early functional treatment vs. early immobilization of Achilles tendon in tension No patient oriented outcome Majewski M;Rohrbach M;Czaja S;Ochsner P; Avoiding sural nerve injuries during percutaneous Achilles tendon repair Not best available evidence Attinger CE;Ducic I;Hess CL;Basil A;Abbruzzesse M;Cooper P; Outcome of skin graft versus flap surgery in the salvage of the exposed Achilles tendon in diabetics versus nondiabetics Not relevant Kotnis R;David S;Handley R;Willett K;Ostlere S; Dynamic ultrasound as a selection tool for reducing Achilles tendon re-ruptures Combines open and percutaneous repair Operative treatment of acute Achilles tendon rupture: Open end-to-end-reconstruction versus reconstruction with Mitek-anchors Retrospective case series Acute Achilles tendon rupture: minimally invasive surgery versus nonoperative treatment with immediate full weightbearing--a randomized controlled trial Not Relevant Schonberger TJ;Janzing HM;Morrenhof JW;de Visser AC;Muitjens P; Metz R;Verleisdonk EJ;van der Heijden GJ;Clevers GJ;Hammacher ER;Verhofstad MH;van der WC; Suchak AA;Bostick GP;Beaupre LA;Durand DC;Jomha NM; The influence of early weight bearing compared with All patients do non-weight bearing after surgical repair of the Achilles not receive same tendon treatment 51 v1.0 12.04.09 Author Blankstein A;Israeli A;Dudkiewicz I;Chechik A;Ganel A; Maffulli N;Longo UG;Ronga M;Khanna A;Denaro V; Title Percutaneous Achilles tendon repair combined with real-time sonography Favorable Outcome of Percutaneous Repair of Achilles Tendon Ruptures in the Elderly Exclusion Reason No patient oriented outcome Not best available evidence Early motion for Achilles tendon ruptures: is surgery important? A randomized, prospective study No relevant outcomes Achilles tendon after percutaneous surgical repair: serial MRI observation of uncomplicated healing No patient oriented outcome Randomised controlled trials of immediate weight bearing mobilisation for rupture of the tendo Achillis Not Relevant Carter TR;Fowler PJ;Blokker C; Functional postoperative treatment of Achilles tendon repair Retrospective Perez TA; Traumatic rupture of the Achilles Tendon. Reconstruction by transplant and graft using the lateral peroneus brevis Martinelli B; Percutaneous repair of the Achilles tendon in athletes Twaddle BC;Poon P; Fujikawa A;Kyoto Y;Kawaguchi M;Naoi Y;Ukegawa Y; Costa ML;MacMillan K;Halliday D;Chester R;Shepstone L;Robinson AH;Donell ST; Gorschewsky O;Pitzl M;Putz A;Klakow A;Neumann W; Mullaney MJ;McHugh MP;Tyler TF;Nicholas SJ;Lee SJ; Rumian AP;Molloy S;Solan M;Newman KJ;Elliott D; Ebinesan AD;Sarai BS;Walley GD;Maffulli N; Percutaneous repair of acute Achilles tendon rupture Weakness in end-range plantar flexion after Achilles tendon repair Surgical repair of the Achilles tendon: The lateral approach Insufficient Quantitative Data Not best available evidence Insufficient Quantitative Data No patient oriented outcome Not best available evidence Conservative, open or percutaneous repair for acute rupture of the Achilles tendon Retrospective comparative Chan SK;Chung SC;Ho YF; Minimally invasive repair of ruptured Achilles tendon Retrospective Lildholdt T;MunchJorgensen T; Conservative treatment to Achilles tendon rupture. A follow-up study of 14 cases No description of surgery 52 v1.0 12.04.09 Author Title Nistor L; Surgical and non-surgical treatment of Achilles Tendon rupture. A prospective randomized study Haggmark T;Liedberg H;Eriksson E;Wredmark T; Kangas J;Pajala A;Siira P;Hamalainen M;Leppilahti J; Calf muscle atrophy and muscle function after nonoperative vs operative treatment of Achilles tendon ruptures Early functional treatment versus early immobilization in tension of the musculotendinous unit after Achilles rupture repair: a prospective, randomized, clinical study Exclusion Reason Not best available evidence No patient oriented outcome Not Relevant Insufficient Quantitative Data No patient oriented outcome Surgeons did not follow same technique Not best available evidence Synder M;Zwierzchowski H; Post-operative results in fresh injuries the Achilles tendon Therbo M;Petersen MM;Nielsen PK;Lund B; Loss of bone mineral of the hip and proximal tibia following rupture of the Achilles tendon Solveborn SA;Moberg A; Immediate free ankle motion after surgical repair of acute Achilles tendon ruptures Kakiuchi M; A combined open and percutaneous technique for repair of tendo Achillis. Comparison with open repair Buchgraber A;Passler HH; Percutaneous repair of Achilles tendon rupture. Immobilization versus functional postoperative treatment No baseline data Speck M;Klaue K; Early full weightbearing and functional treatment after surgical repair of acute Achilles tendon rupture No baseline data Aoki M;Ogiwara N;Ohta T;Nabeta Y; Early active motion and weightbearing after crossstitch Achilles tendon repair Insufficient Data Dargel J;Ninck J;Koebke J;Appell HJ;Pennig D;Hillekamp J; Influence of knee flexion on plantarflexion moments after open or percutaneous Achilles tendon repair Retrospective comparative Follak N;Ganzer D;Merk H; The utility of gait analysis in the rehabilitation of patients after surgical treatment of Achilles tendon rupture No relevant patient oriented outcomes Isokinetic strength and strength endurance of the lower limb musculature ten years after Achilles tendon repair All patients did not receive exact surgery Functional treatment after surgical repair of acute Achilles tendon rupture: wrap vs walking cast Not Relevant Horstmann T;Lukas C;Mayer F;Winter E;Ambacher T;Heitkamp H;Dickhuth H; Kerkhoffs GM;Struijs PA;Raaymakers EL;Marti RK; 53 v1.0 12.04.09 Author Title Exclusion Reason Soldatis JJ;Goodfellow DB;Wilber JH; End-to-end operative repair of Achilles tendon rupture Retrospective Cetti R; Ruptured Achilles tendon--preliminary results of a new treatment No baseline data Cetti R;Henriksen LO;Jacobsen KS; A new treatment of ruptured Achilles tendons. A prospective randomized study 54 Not Relevant v1.0 12.04.09 STUDY QUALITY Table 60. Study Quality Aktas, et al. 2007 Pain - Mild w/ maximal exertion‡ Aktas, et al. 2007 Pain - Absent‡ Bhattacharyya, et al. 2009 Return to Normal Walking (weeks) Return to Normal Stair Climbing (weeks) Return to Normal Walking (weeks) Return to Normal Stair Climbing (weeks) Return to work (weeks) Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 Cetti, et al. 1993 Treatment LoE Same Treatments Equal Follow up Time Outcome Measure 30 Open Repair IV ● ● ● ● ● 30 Open Repair IV ● ● ● ● ● 53 Open Repair IV ● ● ● ● ● 53 Open Repair IV ● ● ● ● ● 53 Minimally Invasive Repair IV ● ● ● ● ● 53 Minimally Invasive Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● N Consecutive Enrollment Follow up <80% Author Same Outcomes ● = Yes ○ = No × = Not Reported Cetti, et al. 1993 Return to sports diminished level 56 Open Repair IV ● ● ● ● ● Cetti, et al. 1993 Return to sports same level 56 Open Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● Cetti, et al. 1993 Cetti, et al. 1993 Cetti, et al. 1993 Cetti, et al. 1993 Return to sports stopped FunctionAbnormal ankle movement FunctionAbnormal ankle movement FunctionAbnormal gait Cetti, et al. 1993 FunctionAbnormal gait 56 Open Repair IV ● ● ● ● ● Cetti, et al. 1993 FunctionAbnormal run 56 Open Repair IV ● ● ● ● ● 55 v1.0 12.04.09 Cetti, et al. 1993 Cetti, et al. 1993 Chillemi, et al. 2002 Chillemi, et al. 2002 Coutts, et al 2002 ES Ng, et al. 2007 FunctionAbnormal run FunctionAbnormal toe stand FunctionAbnormal toe stand Able to walk without limitation Return to sports activity (frequent participant 2-3 times per week) Return to preinjury sporting level Return to activity - same level Gigante, et al. 2008 SF-12 - Physical Component Score Gigante, et al. 2008 SF-12 - Mental Component Score Return to active sporting/outdoor activities Return to active sporting/outdoor activities Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Return to ADL Return to final functional activity Satisfaction Excellent Return to final functional activity Treatment LoE Same Treatments Equal Follow up Time Cetti, et al. 1993 Outcome Measure 56 Open Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● 56 Open Repair IV ● ● ● ● ● 38 Percutaneous Repair IV ● ● ● ● ● 14 Percutaneous Repair IV ● ● ● ● ● 22 Open Repair IV ○ ● ● ● ● 25 Percutaneous Repair IV ● ● ● ● ● 19 Percutaneous Repair IV ● ● ● ● ● 19 Percutaneous Repair IV ● ● ● ● ● 33 Open Repair IV ● ● ● ● ● 33 Percutaneous Repair IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● N 33 Open Repair Consecutive Enrollment Follow up <80% Author Same Outcomes ● = Yes ○ = No × = Not Reported Open Repair 33 33 33 Open Repair Percutaneous Repair 56 v1.0 12.04.09 Lim, et al. 2001 Lim, et al. 2001 Return to active sporting/outdoor activities Return to active sporting/outdoor activities Satisfaction Excellent Treatment LoE Same Treatments Equal Follow up Time Lim, et al. 2001 Outcome Measure 33 Percutaneous Repair IV ● ● ● ● ● 33 Percutaneous Repair IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● IV ● ● ● ● ● N 33 Metz, et al. 2008 Return to work 40 Metz, et al. 2008 Return to sports 40 Metz, et al. 2008 Change sports 40 Metz, et al. 2008 Stop sports 40 Return to Moller, et al. 2001 sedentary work (days) Return to light, Moller, et al. 2001 mobile work (days) Return to work Moller, et al. 2001 (days) Return to heavy Moller, et al. 2001 work (days) Return to sports Moller, et al. 2001 same level Moller, et al. 2001 Moller, et al. 2001 Moller, et al. 2001 Moller, et al. 2001 Moller, et al. 2001 Return to sports stopped Return to sedentary work (days) Return to light, mobile work (days) Return to work (days) Return to heavy work (days) Percutaneous Repair Minimally Invasive Repair Minimally Invasive Repair Minimally Invasive Repair Minimally Invasive Repair Consecutive Enrollment Follow up <80% Author Same Outcomes ● = Yes ○ = No × = Not Reported 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● 59 Open Repair IV ● ● ● ● ● Open Repair IV ● ● ● ● ● 59 57 v1.0 12.04.09 Pain-during walking Moller, et al. 2001 Pain-moderate Moller, et al. 2001 Pain-none Uchiyama, et al. Return to jogging 2007 (weeks) Return to same Uchiyama, et al. level of sports 2007 (months) (high level athletes) Moller, et al. 2001 N Treatment LoE Same Treatments Equal Follow up Time Outcome Measure 59 Open Repair IV ● ● ● ● ● 59 59 Open Repair Open Repair IV IV ● ● ● ● ● ● ● ● ● ● 84 Open Repair IV ○ ● ● ● ● 84 Open Repair IV ○ ● ● ● ● Consecutive Enrollment Follow up <80% Author Same Outcomes ● = Yes ○ = No × = Not Reported Aktas, et al.Aktas, et al.2009 Pain 46 Minimally Invasive Repair IV ● ● ● ● ● Aktas, et al.Aktas, et al.2009 Pain 46 Open Repair IV ● ● ● ● ● 58 v1.0 12.04.09 RECOMMENDATION 6 In the absence of reliable evidence, it is the opinion of the work group that although operative treatment is an option , it should be approached more cautiously in patients with diabetes, neuropathy, immunocompromised states, age above 65, tobacco use, sedentary lifestyle, obesity (BMI >30), peripheral vascular disease or local/systemic dermatologic disorders. AAOS Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. Rationale: Rupture of the Achilles tendon occurs not only in healthy active individuals, but also in those with substantial medical histories. We were unable to find any published studies that addressed the effects of co-morbid conditions on the success of operative repair. Therefore, this recommendation is based on expert opinion, and is consistent with current clinical practice. The consensus of the work group is that consideration of non-operative treatment should occur before performing operative repair of Achilles tendon ruptures in those individuals with conditions that may impair wound healing. These individuals may be at increased risk for wound problems and infection with subsequent detrimental effect on outcome. Supporting Evidence: We did not identify any studies to address this recommendation. 59 v1.0 12.04.09 RECOMMENDATION 7 For patients who will be treated operatively for an acute Achilles tendon rupture, we are unable to recommend for or against preoperative immobilization or restricted weight bearing. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: We were unable to find any published studies that addressed the effects of preoperative immobilization or restricted weight bearing on the success of operative repair of acute rupture of this tendon. Supporting Evidence: We did not identify any studies to address this recommendation. 60 v1.0 12.04.09 RECOMMENDATION 8 Open, limited open and percutaneous techniques are options for treating patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale: We defined the following operative repairs: Open – procedure utilizing an extended incision for exposure allowing visualization of the rupture and tendon to allow direct placement of sutures for the repair. Limited-Open – procedure utilizing a small incision for exposure allowing direct visualization of the ruptured ends. Percutaneous – procedure without direct exposure of the tendon rupture site. A systematic review identified three level II comparative trials29, 33, 35 investigating percutaneous repair and one level II and two level III comparative trials studying limitedopen repairs.27, 36, 31 In both these comparisons, there was no significant difference in reruptures between open and minimally invasive techniques. Two studies 29, 33 that compared percutaneous to open repairs found no statistically significant difference in return to activity. Two studies27, 36 comparing limited open to open repair found that patients treated with a limited open technique returned to activity sooner than those treated with an open repair. There is no statistically significant difference in satisfaction in patients treated with percutaneous or open repairs.29 Patients treated with limited open repair techniques have statistically significantly fewer symptoms than those treated with open technique but no statistically significant differences in pain. One study33 showed a statistically significant difference in the short term in favor of the percutaneous group for wound breakdown/delayed healing. Two studies29, 33 showed statistically significantly less scar adhesion in the percutaneous repair group compared with the open repair. Similarly, patients treated with limited open groups had statistically 61 v1.0 12.04.09 significantly fewer minor surgical site infections leading to delayed wound healing and in one study fewer severe wound infections.27 Beyond short term wound complications, there is no identified added benefit when comparing long term adverse events between open repair and minimally invasive repair. While in some studies33, 31 there were an increased number of superficial infections in the open repair group, there was no statistically significant difference between groups for deep infections31. One study29 reported a statistically significant difference in superficial infections between the open group and percutaneous groups, however, the authors29 did not administer IV antibiotics to the open control group. Based on these considerations, we downgraded this body of evidence to limited. The literature reviewed refers primarily to non insertional ruptures in which there is sufficient distal tendon for repair. It is acknowledged that a small subset of ACTR consist of purely insertional injuries, often with a segment of bone attached. The latter group is beyond the scope of this GL. However, the reader should be aware of the fact that the repair techniques reviewed may not be compatible with these distal ruptures. Consideration should also be given to the location of the tear when performing a repair in a percutaneous or limited-open fashion. Tears located at the proximal or distal ends of the tendon may compromise the ability to successfully complete a limited open repair. The orthopaedic surgeon performing the repair may need to extend the incision, converting it to an open technique if unable to obtain good suture fixation with a limitedopen or percutaneous technique. Supporting Evidence: We examined studies that made two different comparisons. Two level II studies compared percutaneous repair to open repair.29, 35 Two level II studies and two level III studies compared limited open to open repair.31,33 27, 36 PERCUTANEOUS VS OPEN REPAIR Patients treated with percutaneous repair scored significantly higher on the SF-12 physical and mental component scores (see Table 61). There was no significant difference in the amount of patients who returned to functional activities, activities of daily living, (see Table 62) or patient satisfaction (see Table 63). The amount of reruptures did not significantly differ between treatment groups (see Table 65) Studies29, 33 reported no significant difference in the number of sural nerve injuries, superficial infection with staphalococcus, hypertonic scars, or keloid formation (Table 64). Patients treated with percutaneous repair had significantly less wound breakdown/delay of healing as well as less scar adhesions (see Table 64). No significant difference in the amount of deep infections was reported. One study29 reported a statistically significant difference in superficial infection, while another study33 did not report a difference(see Table 64). However, the study which did report more superficial infections in the open repair group, did not administer IV antibiotics. Wound puckering occurred significantly more in patients treated with percutaneous repair (see Table 64). 62 v1.0 12.04.09 SUMMARY OF EVIDENCE- PERCUTANEOUS VS. OPEN Table 61. Percutaneous and Limited Open vs. Open - Global Outcomes Author Outcome LOE N Duration 24 months Gigante SF-12 - Physical Component Score II 39 ●P SF-12 - Mental II 39 ●P Component Score ● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Gigante Table 62. Percutaneous vs. Open - Return to Activities and Function Author Outcome LOE N Duration (months) 6 65.5 % ES Ng Return to Activity II 68 Lim Return to Activities of Daily Living II 66 ○ ○ Returned to Final II 66 ○ Functional Activity‡ ● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance ‡ Final Functional Activity: “When patient was unhindered in all his or her activities apart from sports.” Lim Table 63. Percutaneous vs. Open - Satisfaction Outcome Author % Duration LOE N 6 months Lim Satisfaction II 66 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 64. Percutaneous vs. Open- Complications Author Adverse Event LOE N Duration (months) 6 63 65.5 v1.0 12.04.09 Author Adverse Event LOE N Duration (months) 6 65.5 Ng Wound breakdown/ delay healing II 68 ●P Ng Sural Nerve Injury II 68 ○ Lim II 66 ○ II 66 ○ Lim Sural Nerve Problems Deep Infection with staphalococcus Adhesions II 66 ●P Ng Scar Adhesion II 68 ●P Ng Superficial Infection II 68 ○ Lim II 66 Ng Superficial Infection Superficial Infection with staphalococcus Hypertrophic Scar II 68 Lim Keloid Formation II 66 Lim Lim ●P ○ ○ ○ Lim Wound Puckering II 66 ● Op ● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 65. Percutaneous vs. Open- Rerupture Author Adverse Event LOE N Duration (months) 6 65.5 Lim et al 2001 Rerupture II 66 ○ Ng, et al 2006 Rerupture II 68 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance LIMITED OPEN VS OPEN REPAIR Patients treated with limited open repair did not have less pain or score higher on the AOFAS scale than patients treated with open repair (see Table 66 and Table 67). Patients treated with limited open repair returned to normal walking, stair climbing, and sports in significantly less time than patients treated with standard open repair (seeTable 68). A significantly larger percentage of patients treated with limited open repair had fewer symptoms compared to patients treated with open repair (seeTable 69). There was no significant difference in the number of reruptures between treatment groups (see Table 71). There was no statistically significant difference in DVT, large hematoma, 64 v1.0 12.04.09 stiffness of ankle, insertional tendinopathy, or deep infection between the open and limited repair groups (see Table 70). However, patients treated with limited open repair had significantly fewer severe wound infections, superficial infections, and minor surgical site infections than patients treated with open repair (see Table 70). SUMMARY OF EVIDENCE- LIMITED OPEN VS. OPEN Table 66. Minimally Invasive vs. Open- Pain Outcome Author % Duration LOE N 6 months Aktas Pain II 46 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 67. Minimally Invasive vs. Open- Global Outcomes Author Outcome LOE N Duration 24 months Aktas AOFAS II 40 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 68. Limited Open vs. Open- Return to Activity Outcome Author (weeks) LOE N Duration 63.5 12 months months Bhattacharyya Return to Normal Walking III 53 ●Mini Bhattacharyya Return to Normal Stair Climbing III 53 ●Mini Kakiuchi Return to Sports III 22 ● Mini ● Mini: Statistically Significant in Favor of Minimally Invasive (mini-open) Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 69. Mini-Open vs. Open- Symptoms Author Kakiuchi Outcome (%) Symptoms LOE N III 22 Duration 63.5 months ● Mini ● Mini: Statistically Significant in Favor of Minimally Invasive Repair 65 v1.0 12.04.09 ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 70. Limited Open Repair vs. Open - Complications Author Bhattacharyya Bhattacharyya Complication Minor Surgical Site Infection with Delayed Wound Healing Severe Wound Infection and Dehiscence LOE N Duration 6 12 Months months III 53 ● Mini III 53 ● Mini Aktas, 2009 Deep Infection II 40 ○ Aktas, 2009 Superficial Infection II 40 ● Mini Aktas, 2009 Insertional Tendinopathy II 40 ○ Aktas, 2009 Stiffness of the ankle II 40 ○ Aktas, 2009 Large Hematoma II 40 ○ Aktas, 2009 DVT II 40 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 71. Mini-Open vs. Open – Rerupture Author Adverse Events LOE N Duration 63.5 months Kakiuchi Rerupture III 22 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance 66 v1.0 12.04.09 EXCLUDED ARTICLES Table 72. Excluded Studies - All Operative Techniques Author Cretnik A, et al Wagnon R, et al Assal M, et al Title Percutaneous versus open repair of the ruptured Achilles tendon. a comparative study The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures. a functional and MRI assessment Limited open repair of Achilles tendon ruptures. a technique with a new instrument and findings of a prospective multicenter study Halasi T, et al Percutaneous Achilles tendon repair with and without endoscopic control Cretnik A, et al Percutaneous suturing of the ruptured Achilles tendon under local anesthesia Coutts A, et al Clinical and functional results of open operative repair for Achilles tendon rupture in a non-specialist surgical unit Calder JD, et al Independent evaluation of a recently described Achilles tendon repair technique Uchiyama E, et al A modified operation for Achilles tendon ruptures Maes R, et al; Is percutaneous repair of the Achilles tendon a safe technique? A study of 124 cases Amlang MH, et al The percutaneous suture of the Achilles tendon with the Dresden instrument Tang KL, et al Arthroscopically assisted percutaneous repair of fresh closed Achilles tendon rupture by Kessler's suture Fortis AP, et al Repair of Achilles tendon rupture under endoscopic control Schonberger TJ, et al Hohendorff B, et al Kuwada GT; Operative treatment of acute Achilles tendon rupture. Open end-to-end-reconstruction versus reconstruction with Mitek-anchors Long-term results after operatively treated Achilles tendon rupture. fibrin glue versus suture Critical analysis of tendo Achillis repair using Achilles tendon rupture classification system and repair 67 Exclusion Reason Not best available evidence Not best available evidence Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Retrospective case series suture technique Not best available evidence - not comparative v1.0 12.04.09 Author Title Exclusion Reason Lansdaal JR, et al The results of 163 Achilles tendon ruptures treated by a minimally invasive surgical technique and functional after treatment Not best available evidence - not comparative Blankstein A, et al Percutaneous Achilles tendon repair combined with realtime sonography Majewski M, et al Avoiding sural nerve injuries during percutaneous Achilles tendon repair Jung HG, et al Outcome of Achilles tendon ruptures treated by a limited open technique Scarfi G, et al Percutaneous repair of Achilles tendon Crnica S, et al Follow-up results of Achilles tendon rupture treatment by the method of modified percutaneous suture Perez TA; Traumatic rupture of the Achilles Tendon. Reconstruction by transplant and graft using the lateral peroneus brevis Ma GW;Griffith TG; Percutaneous repair of acute closed ruptured Achilles tendon. a new technique Boyden EM, et al; Late versus early repair of Achilles tendon rupture. Clinical and biomechanical evaluation Soldatis JJ, et al End-to-end operative repair of Achilles tendon rupture Martinelli B; Percutaneous repair of the Achilles tendon in athletes Mellor SJ;Patterson MH; Tendo Achillis rupture; surgical repair is a safe option Bruggeman NB, et al Wound complications after open Achilles tendon repair. an analysis of risk factors Webb JM;Bannister GC; Percutaneous repair of the ruptured tendo Achillis Gillespie HS;George EA; Results of surgical repair of spontaneous rupture of the Achilles tendon Jessing P;Hansen E; Surgical treatment of 102 tendo achillis ruptures-- suture or tenontoplasty? 68 Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative v1.0 12.04.09 Author Title Kiviluoto O, et al Surgical repair of subcutaneous rupture of the Achilles tendon Haggmark T, et al Calf muscle atrophy and muscle function after nonoperative vs. operative treatment of Achilles tendon ruptures Bomler J;Sturup J; Achilles tendon rupture. An 8-year follow up Hogsaa B, et al Surgical treatment of Achilles tendon ruptures FitzGibbons RE, et al Percutaneous Achilles tendon repair Chillemi C, et al Percutaneous repair of Achilles tendon rupture. Ultrasonographical and isokinetic evaluation Gorschewsky O, et al Percutaneous repair of acute Achilles tendon rupture Exclusion Reason Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative Stochastic Randomization Allocation Concealment Patients Blinded Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry STUDY QUALITY Table 73. Study Quality - RCTs Level II ● × × ● ● × Level II ● × × ● ● × Level II ○ ● ● × ● × Level II ○ ● ● × ● × ● = Yes ○ = No × = Not Reported Author Outcome N Gigante, et al. 2008 SF-12. Physical Component 39 Gigante, et al. 2008 SF-12. Mental Component 39 Lim, et al. 2001 Complications 66 Lim, et al. Duration of Immobilization 66 Treatment(s) Open Repair vs. Percutaneous Repair Open Repair vs. Percutaneous Repair Open Repair vs. Percutaneous Repair Open Repair vs. Level of Evidence 69 v1.0 12.04.09 Stochastic Randomization Allocation Concealment Patients Blinded Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry Level II ○ ● ● × ● × Level II ○ ● ● × ● × Level II × × × ○ ● ● ● = Yes ○ = No × = Not Reported Author Outcome N 2001 Lim, et al. 2001 Return to activities of daily living 66 Lim, et al. 2001 Return to functional activity 66 Aktas, et al. 2009 AOFAS 40 Treatment(s) Percutaneous Repair Open Repair vs. Percutaneous Repair Open Repair vs. Percutaneous Repair Minimally Invasive vs. Open Level of Evidence 70 v1.0 12.04.09 Level of Evidence All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data Table 74. Quality of Studies - Comparative Studies Level III × × ● ○ ● Level III × × ● ○ ● Level III × × ● ○ ● Level III × × ● ○ ● Level III × × ● ○ ● Level III × × ● ○ ● Level II ● × ● ● ● Level II ● × ● ● ● Level III ○ × ● ● ● Level III ○ × ● ● ● Level III ○ × ● ● ● ● = Yes ○ = No × = Not Reported Author Outcome Kakiuchi, et al. 1995 Return to Sports 22 Kakiuchi, et al. 1995 Symptoms None 22 Kakiuchi, et al. 1995 Symptoms Stiffness 22 Kakiuchi, et al. 1995 Symptoms Discomfort 22 Kakiuchi, et al. 1995 Symptoms Pain 22 Kakiuchi, et al. 1995 Re-rupture 22 Ng, et al. 2006 Return to Activity Same Level 68 Ng, et al. 2006 Complications 68 Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 Return to Normal Walking Return to Normal Stair Climbing Severe Wound Infection and N 53 53 53 Treatment(s) Percutaneous and Minimally Invasive vs. Open Repair Percutaneous and Minimally Invasive vs. Open Repair Percutaneous and Minimally Invasive vs. Open Repair Percutaneous and Minimally Invasive vs. Open Repair Percutaneous and Minimally Invasive vs. Open Repair Percutaneous and Minimally Invasive vs. Open Repair Percutaneous vs. Open Repair Percutaneous vs. Open Repair Minimally Invasive vs. Open Repair Minimally Invasive vs. Open Repair Minimally Invasive vs. Open Repair 71 v1.0 12.04.09 Level of Evidence All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data Level III ○ × ● ● ● Level III ○ × ● ● ● ● = Yes ○ = No × = Not Reported Author Outcome N Treatment(s) Dehiscence Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 Minor Surgical Site Infection Delayed Wound Healing 53 53 Minimally Invasive vs. Open Repair Minimally Invasive vs. Open Repair 72 v1.0 12.04.09 STUDY RESULTS Table 75. Limited open vs. Open - Global Outcomes Author Outcome Gigante, et al. 2008 LOE SF-12 - Physical Component Score SF-12- Mental Component Score N Duration Minimally Invasive Open mean (SD) mean (SD) Results II 39 24 months 52.6 (2.31) 50.7 (2.57) p = 0.02‡ II 39 24 months 52.2 (1.91) 50.4 (2.75) p = 0.02‡ ‡ AAOS calculation Table 76. Percutaneous vs. Open - Return to Activities Author Outcome Lim, et al. 2001 Lim, et al. 2001 Return to Activities of Daily Living Returned to Final Functional Activity LOE N Duration Percutaneous (%) Open (%) Results II 66 6 months 100% 100% NS II 66 6 months 100% 100% NS NS: not significant; authors do not report p-value Table 77. Percutaneous vs. Open - Satisfaction Author Outcome LOE N Duration Percutaneous (%) Open (%) Results Lim, et al. 2001 Satisfaction Excellent II 66 6 months 52% 42% NS NS: not significant; authors do not report p-value Table 78. Percutaneous vs. Open - Complications Author Lim, et al 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 N Duration Percutaneous (%) Open (%) Results II 66 6 months 3% 6% p = .55‡ II 66 6 months 3% 0% p = .15‡ II 66 6 months 0% 3% II 66 6 months 0% 3% Complications LOE Re-rupture Sural Nerve Problems Deep infection with wound breakdown and staphalococcus infection Superficial Infection with staphalococcus infection 73 p = 0.155‡ p = 0.155‡ v1.0 12.04.09 Author N Duration Percutaneous (%) Open (%) Results II 66 6 months 0% 15% p=0.001‡ II 66 6 months 0% 3% p = .15‡ Adhesions II 66 6 months 0% 6% p = .043 Wound Puckering II 66 6 months 9% 0% p = .013‡ Deep Infection II 40 Post operative 0% 5% p=0.15‡ II 40 0% 15% p=0.011‡ II 40 5% 0 p=0.15‡ II 40 0% 5% p=0.15‡ II 40 0% 5% p=0.15‡ II 40 0% 5% p=0.15‡ Complications LOE Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Lim, et al. 2001 Aktas, et al. 2009 Superficial Infection Keloid Formation Aktas, et al. Superficial 2009 Infection Aktas, et al. Insertional 2009 Tendinopathy Aktas, et al. Stiffness of the 2009 ankle Aktas, et al. Large 2009 Hematoma Aktas, et al. DVT 2009 ‡ AAOS calculation Post operative Post operative Post operative Post operative Post operative Table 79. Minimally Invasive vs. Open- Pain Author Aktas, et al. 2009 Outcome LOE N Duration Percutaneous (%) Open (%) Results Pain II 46 22 months 4.5% 13% P=0.3 Table 80. Minimally Invasive vs. Open- Global Outcomes Author Aktas, et al. 2009 Outcome LOE N Duration Percutaneous (%) Open (%) Results Pain II 46 22 months 4.5% 13% P=0.3 Table 81. Minimally Invasive vs. Open - Function Author Outcome Bhattacharyya, et al. 2009 Return to Normal Walking (weeks) Return to Normal Stair Climbing (weeks) LOE N Duration Minimally Invasive mean (SD) Open Repair mean (SD) Results III 53 12 months 12.5 (3)‡ 17 (3)‡ p ≤ .001‡ III 53 12 months 14 (3)‡ 19 (3.5)‡ p ≤ .001‡ 74 v1.0 12.04.09 Author Outcome Return to Activity - Same Level ‡ AAOS calculation Ng, et al 2006 LOE N Duration Minimally Invasive mean (SD) Open Repair mean (SD) Results II 68 65.5 months 96% 88% p = 0.244 Open (%) Results Table 82. Minimally Invasive vs. Open - Complications Author Bhattacharyya, et al. 2009 Bhattacharyya, et al. 2009 Complications Minor Surgical Site Infection with Delayed Wound Healing Severe Wound Infection and Dehiscence Ng, et al. Re-rupture 2006 Ng, et al. Sural Nerve 2006 Injury Ng, et al. Superficial 2006 Infection Ng, et al. Hypertrophic 2006 Scar Ng, et al. Scar Adhesion 2006 Ng, et al. Wound 2006 Breakdown/delay ‡ AAOS calculation LOE N Duration Minimally Invasive Open Repair (%) III 53 12 months 0% 17% III 53 12 months 0% 7% p =.034‡ II 68 0% 2% p = .223‡ II 68 0% 2% p = .22‡ II 68 8% 5% p = .58‡ II 68 4% 19% p = .052‡ II 68 0% 9% p = .014‡ II 68 0% 12% p = .005‡ 65.5 months 65.5 months 65.5 months 65.5 months 65.5 months 65.5 months p <.001‡ Table 83. Minimally Invasive vs. Open - Symptoms Author Outcome Kakiuchi, et al. Symptoms - Pain 1995 Kakiuchi, et al. Symptoms- None 1995 Kakiuchi, et al. Symptoms 1995 Stiffness Kakiuchi, et al. Symptoms 1995 Discomfort ‡ AAOS calculation LOE N III 22 III 22 III 22 III 22 Duration 63.5 months 63.5 months 63.5 months 63.5 months 75 Minimally Invasive (%) Open (%) Results 0% 20% p = .05‡ 83% 40% p <.001‡ 17% 30% p =.78‡ 0% 10% p = .17‡ v1.0 12.04.09 Table 84. Minimally Invasive vs. Open - Return to Sport Author Outcome Return to Sport Same or increased level Return to Sport Kakiuchi, et al. Decreased 1995 Return to Sport No participation for other reasons ‡ AAOS calculation Open (%) Results 75% 10% p < .001‡ 63.5 months 8% 40% p = .17‡ 63.5 months 17% 50% p = .27‡ Minimally Invasive (%) Open % % 0% 0% LOE N Duration III 22 63.5 months III 22 III 22 Minimally Invasive (%) Table 85. Minimally Invasive vs. Open - Complications Author Complications LOE N Duration Kakiuchi, et al. 63.5 Rerupture III 22 1995 months NS: not significant; authors do not report p-value 76 Results NS v1.0 12.04.09 RECOMMENDATION 9 We cannot recommend for or against the use of allograft, autograft, xenograft, synthetic tissue, or biologic adjuncts in acute Achilles tendon ruptures that are treated operatively. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale A systematic review failed to identify adequate evidence to make a recommendation for or against the use of allograft, autograft, xenograft, synthetic tissue, or biologic adjuncts in acute Achilles tendon ruptures that are treated operatively. No studies addressed adjunctive augmentation with allograft, xenograft, or biologic adjuncts. Three level II studies32, 37, 38 compared open repair alone and autograft augmentation. One level IV study39 compared patients treated with synthetic tissue augmentation to open repair alone. All four of these studies failed to demonstrate significant improvement in outcomes or complications. Supporting Evidence: No studies were identified that address adjunctive augmentation with allograft (see Table 92), xenograft, or biologic adjuncts (see Table 95). We examined three level II studies that compared patients given adjunctive augmentation with autograft tissue vs. open repair.32, 37, 38 One Level IV study that compared patients given adjunctive augmentation with synthetic tissue vs. open repair.39 AUTOGRAFT TISSUE VS OPEN REPAIR Three studies reported that patients given adjunctive augmentation did not significantly differ in pain, stiffness, satisfaction, return to daily activities, return to sport, or footwear restrictions (see Table 86 - Table 89). One study reported one patient given adjunct augmentation had a pulmonary embolism; no significant difference was found between treatment groups (see Table 91). In two studies, DVT rates did not significantly differ in patients given augmentation with autograft tissue vs. open repair. Two studies reported patients with deep infection. One study found patients treated with open repair had significantly less deep infections and 77 v1.0 12.04.09 the other study reported no significant difference. No significant differences were found in patients given augmentation with superficial infections, dysesthesia, Keloid, and dehiscence (see Table 91). AUGMENTATION WITH SYNTHETIC TISSUE VS OPEN REPAIR We analyzed one non-comparative study that analyzed patients treated with synthetic tissue (polypropylene braid). All patients reported excellent results and all patients returned to previous activity (see Table 106). There were no reruptures and no healing impairment (see Table 106). One patient underwent a PB removal procedure 1 year after surgery because of the distal heat-sealed end of the PB device stuck out of the tendon, causing an impingement on the shoe (see Table 106). SUMMARY OF EVIDENCE Table 86. Autograft vs. Open - Pain and Stiffness Author LOE N Outcome Pajala II 59 Pain Aktas II 30 Pain Taglialavoro II 46 Pain Pajala II 59 Stiffness Duration (months) 6 12 42 ○ ○ ○ ○ ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 87. Autograft vs. Open - Satisfaction Author LOE N Outcome Taglialavoro II 46 Satisfaction Pajala II 59 Satisfaction Duration (months) 12 42 ○ ○ ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 88. Autograft - Return to Activities and Sports Author LOE N Taglialavoro II 46 Outcome Recovery of Daily Activities (days) 78 Duration (months) 6 42 ○ v1.0 12.04.09 Author LOE N Taglialavoro II 46 Aktas, et al II 30 Duration (months) 6 42 Outcome Return to Sports – Complaints during normal activity Return to Sports – Same Level / Pre-injury ○ ○ Taglialavoro II 46 Return to Sports ○ ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 89. Autograft vs. Open - Footwear Restrictions Duration (months) 12 42 Author LOE N Outcome Pajala II 59 Footwear Restrictions Taglialavoro II 46 Conflict with shoes ○ ○ ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 90. Autograft vs. Open - Hospitalization and Immobilization Author Outcome (Days) LOE N Duration 42 months Taglialavoro Hospitalization II 46 ●Op Taglialavoro Immobilization II 46 ●Op ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 91. Autograft vs. Open - Complications Author LOE N Outcome Duration (months) 6 12 Taglialavoro II 46 PE 42 ○ Taglialavoro II 46 DVT ○ Pajala II 60 DVT Aktas II 30 Deep Infection Pajala II 60 Deep Infection ●Op Pajala II 60 Superficial ○ ○ 79 ○ v1.0 12.04.09 Author LOE N Outcome Duration (months) 6 12 42 Infection ○ Pajala II 60 Re-rupture Aktas II 30 Re-rupture Taglialavoro II 46 Dysesthesia ○ Taglialavoro II 46 Keloid ○ ○ Taglialavoro II 46 Dehiscence ○ ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance EXCLUDED ARTICLES Table 92. Excluded Studies - Allograft Author Title Exclusion Reason Bleakney, et al. 2005 Imaging of the Achilles tendon Commentary Lee, et al. 2007 Achilles tendon repair with acellular tissue graft augmentation in neglected ruptures Neglected/chronic Achilles tear patients Table 93. Excluded Studies - Autograft Author Title Exclusion Reason Bradley, et al. 1990 Percutaneous and open surgical repairs of Achilles tendon ruptures. A comparative study Not best available evidence Coull, et al. 2003 Flexor hallucis longus tendon transfer: evaluation of postoperative morbidity Not best available evidence Cretnik, et al. 2004 Incidence and outcome of rupture of the Achilles tendon Not best available evidence Dekker, et al. 1977 Elias, et al. 2007 Garabito, et al. 2005 Hahn, et al. 2008 Jessing, et al. 1975 Results of surgical treatment of rupture of the Achilles tendon with use of the plantaris tendon Reconstruction for missed or neglected Achilles tendon rupture with V-Y lengthening and flexor hallucis longus tendon transfer through one incision Augmented repair of acute Achilles tendon ruptures using gastrocnemius-soleus fascia Treatment of chronic Achilles tendinopathy and ruptures with flexor hallucis tendon transfer: clinical outcome and MRI findings Surgical treatment of 102 tendo achillis ruptures-- suture or tenontoplasty? 80 Not best available evidence Neglected/chronic Achilles tear patients Not best available evidence Less than 10 patients per group Not best available evidence v1.0 12.04.09 Author Title Exclusion Reason Kiviluoto, et al. 1985 Surgical repair of subcutaneous rupture of the Achilles tendon cast only Leppilahti, et al. 1998 Outcome and prognostic factors of Achilles rupture repair using a new scoring method Not best available evidence Lynn, et al. 1966 Repair of the torn Achilles tendon, using the plantaris tendon as a reinforcing membrane Less than 50% followup Maffulli, et al. 2005 Free gracilis tendon graft in neglected tears of the Achilles tendon Neglected/chronic Achilles tear patients Roberts, et al. 1989 Team physician #6. Surgical treatment of Achilles tendon rupture Not best available evidence Schedl, et al. 1979 Achilles tendon repair with the plantaris tendon compared with repair using polyglycol threads Not best available evidence Stein, et al. 2005 Duthie's biological repair of ruptured Achilles tendons Insufficient Quantitative Data Winter, et al. 1998 Surgical repair of Achilles tendon rupture. Comparison of surgical with conservative treatment Retrospective case series Wong, et al. 2005 Modified flexor hallucis longus transfer for Achilles insertional rupture in elderly patients Less than 10 patients per group Table 94. Excluded Studies - Synthetic Tissue Author Fernandez-Fairen, et al. 1997 Hohendorff, et al. 2008 Title Exclusion Reason Augmented repair of Achilles tendon ruptures Retrospective case series Long-term results after operatively treated Achilles tendon rupture: fibrin glue versus suture Suture Technique Parsons, et al. 1984 Achilles tendon repair with an absorbable polymer-carbon fiber composite Parsons, et al. 1989 Long-term follow-up of Achilles tendon repair with an absorbable polymer carbon fiber composite Combines acute and neglected/chronic Achilles tendon tear patients Patients had prior surgical or conservative treatment Table 95- Biologic Adjuncts Author Title Exclusion Reason Aspenberg, et al. 2007 Stimulation of tendon repair: mechanical loading, GDFs and platelets. A mini-review Review Sanchez, et al. 2007 Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices Less than 10 patients per group 81 v1.0 12.04.09 Stochastic Randomization Allocation Concealment Patients Blinded Follow Up - 80% or more Outcome N Treatment(s) Level of Evidence Those rating outcome Blinded All groups have similar outcome performance at entry STUDY QUALITY Table 96. Study Quality – Autograft RCTs Stiffness 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Footwear Restrictions 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Pain 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Satisfaction 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Re-rupture 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Deep Infection 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × DVT 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Superficial Infection 60 Open vs. Autograft Augmentation Level II ● ● ● ○ ● × Return to sport 30 Open vs. Autograft Augmentation Level II × × ● ○ ● × Pain 30 Open vs. Autograft Augmentation Level II ○ ● ● ○ ● × ● = Yes ○ = No × = Not Reported Author Pajala, et al. 2009 Pajala, et al. 2009 Pajala, et al. 2009 Pajala, et al. 2009 Pajala, et al. 2009 Pajala, et al. 2009 Pajala, et al. 2009 Pajala, et al. 2009 Aktas, et al. 2007 Aktas, et al. 2007 82 v1.0 12.04.09 Stochastic Randomization Allocation Concealment Patients Blinded Follow Up - 80% or more N Treatment(s) Level of Evidence Those rating outcome Blinded Outcome All groups have similar outcome performance at entry Deep Infection 30 Open vs. Autograft Augmentation Level II ○ ● ● ○ ● × Re-rupture 30 Open vs. Autograft Augmentation Level II ○ ● ● ○ ● × ● = Yes ○ = No × = Not Reported Author Aktas, et al. 2007 Aktas, et al. 2007 Follow Up - 80% or more Outcome N Treatment(s) Level of Evidence All groups have similar outcome performance at entry All groups concurrently treated Author All groups have similar characteristics at entry Same center for experimental and control group data Table 97. Study Quality - Autograft Comparative Studies Taglialavoro, et al 2004 Pain 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Recovery of Daily Activities 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Return to Sports 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Satisfaction 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Hospitalization 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● ● = Yes ○ = No × = Not Reported 83 v1.0 12.04.09 N Treatment(s) Level of Evidence All groups have similar outcome performance at entry Follow Up - 80% or more Outcome All groups have similar characteristics at entry All groups concurrently treated Author Same center for experimental and control group data Taglialavoro, et al 2004 Immobilization 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 DVT 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 PE 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Dysesthesia 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Shoe conflict 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Keloid 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● Taglialavoro, et al 2004 Dehiscence 46 Open vs. Autograft Augmentation Level II ● ● ● ● ● ● = Yes ○ = No × = Not Reported 84 v1.0 12.04.09 Consecutive enrollment of patients Follow Up - 80% or more Author Outcome N Treatment(s) Level of Evidence All patients evaluated using same outcome measures All patients receive same treatment All patients have approximately equal follow-up times Table 98. Study Quality - Synthetic Tissue Case Series Giannini et al, 1994 Return to Sports 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● ● = Yes ○ = No × = Not Reported Giannini et al, 1994 Giannini et al, 1994 Giannini et al, 1994 Return to Previous Activity Subjective ResultsExcellent Full weight bearing (weeks) Giannini et al, 1994 Rerupture 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● Giannini et al, 1994 Healing Impairment 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● Giannini et al, 1994 Return to Swimming 15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ● 85 v1.0 12.04.09 STUDY RESULTS Table 99 Autograft vs. Open Pain and Stiffness Author Pajala, et al. 2009 Aktas, et al. 2007 Aktas, et al. 2007 Taglialavoro, et al 2004 Taglialavoro, et al 2004 Taglialavoro, et al 2004 Taglialavoro, et al 2004 Pajala, et al. 2009 Outcome LOE N Duration Adjunctive Augmentation % Open Results % No Pain vs. Pain II 59 12 months 79% (4%) 90% (0%) p = 0.35 Pain - Absent‡ II 30 6 months 94% 86% NS Pain - Mild w/ maximal exertion‡ II 30 6 months 6% 14% NS Pain - Absentª II 46 83% 73% NS II 46 17% 18% NS II 46 0% 5% NS Pain - Continuousª II 46 0% 5% NS No stiffness vs. stiffness II 59 12 months 46% (36% 72% (16%) p = .10 Duration Adjunctive Augmentation (%) Open (%) Results 71% (11%) 71% (19%) p = 0.55 46% 46% p = .98‡ 42% 46% p = .8‡ 13% 0% p = .01‡ 0% 9% p = .04‡ Pain - During Intense Trainingª Pain - During Moderate Trainingª 42 months 42 months 42 months 42 months ‡American Orthopaedic Foot and Ankle Score NS: not significant; authors do not report p-value Table 100. Autograft vs. Open - Satisfaction Author Outcome Pajala, et al. Very satisfied vs. all other 2009 satisfaction levels Taglialavoro, Satisfaction - Very Goodª et al 2004 Taglialavoro, Satisfaction - Goodª et al 2004 Taglialavoro, Satisfaction - Fairª et al 2004 Taglialavoro, Satisfaction - Poorª et al 2004 ª Modified McComis Score ‡ AAOS Calculation LOE N II 59 II 46 II 46 II 46 II 46 12 months 42 months 42 months 42 months 42 months 86 v1.0 12.04.09 Table 101. Autograft vs. Open - Return to Sports Author Outcome Aktas, et al. 2007 Taglialavoro, et al 2004 Taglialavoro, et al 2004 Taglialavoro, et al 2004 Taglialavoro, et al 2004 Return to Sports - Same Level / Pre-injury Return to Sports Complete Return to Sports - Low Loss Return to Sports Decreased Return to Sports - Not Recovered Return to Sports Taglialavoro, Complaints during et al 2004 normal activity ‡ AAOS Calculation LOE N Duration Adjunctive Augmentation (%) Open (%) Results II 30 6 months 85% 89% p = .620‡ II 46 38% 32% NS II 46 50% 55% NS II 46 8% 9% NS II 46 4% 0% NS II 46 0% 5% NS 42 months 42 months 42 months 42 months 42 months NS: not significant; authors do not report p-value Table 102. Autograft vs. Open - Return to Activities Author Outcome Taglialavoro, Recovery of Daily et al 2004 Activities(days) ‡ AAOS Calculation LOE N II 46 Adjunctive Open Duration Augmentation mean(SD) mean (SD) 42 128 (39) 106 (66) months Results p = .17‡ Table 103. Autograft vs. Open - Footwear Restrictions Author Outcome LOE N Duration Adjunctive Augmentation (%) Pajala, et al. 2009 No footwear restrictions vs. footwear restrictions II 60 12 months 79% (4%) 90% (0%) p = 0.35 Taglialavoro, et al 2004 Shoe conflict II 46 42 months 38% 23% NS Open (%) Results ‡ AAOS Calculation NS: not significant; authors do not report p-value 87 v1.0 12.04.09 Table 104. Autograft vs. Open - Hospitalization vs. Immobilization Author Taglialavoro, et al 2004 Taglialavoro, et al 2004 Outcome LOE N Duration Hospitalization (days) II 46 Immobilization (days) II 46 42 months 42 months Adjunctive Augmentation mean (SD) Open mean(SD) Results 8.2 (2.3) 5.0 (1.9) p <.001‡ 63.9 (15.8) 49.5 (10.6) p <.001‡ ‡ AAOS Calculation Table 105. Autograft vs. Open - Complications Author Taglialavoro, et al 2004 Taglialavoro, et al 2004 Pajala, et al. 2009 Complication LOE N Duration Adjunctive Augmentation Open Repair % % Results PE II 46 42 months 4% 0% NS DVT II 46 42 months 4% 14% NS DVT II 60 3 weeks 4% 0% NS Pajala, et al. Deep Infection II 60 12 months 7% 0% p = .04‡ 2009 Aktas et al. Deep Infection II 30 6 months 6% 0% NS 2007 Pajala, et al. Superficial II 60 12 months 4% 13% NS 2009 Infection Pajala, et al. Re-rupture‡ II 60 12 months 11% 9% NS 2009 Aktas et al. Re-rupture II 30 6 months 0% 0% NS 2007 Taglialavoro, Dysesthesia II 46 42 months 13% 14% NS et al 2004 Taglialavoro, Keloid II 46 42 months 8% 5% NS et al 2004 Taglialavoro, Dehiscence II 46 42 months 13% 9% NS et al 2004 ‡ Three of the patients with reruptures had obvious new injury during recovery period. One re-rupture occurred at ten weeks when patient was cycling up a steep hill. Two re-ruptures occurred at twelve weeks with minimum trauma; these patients were in the Open repair group and recalled having sustained a slight injury during the first three weeks. ‡ AAOS calculation NS: Non-Significant; Authors did not report p-value 88 v1.0 12.04.09 Table 106. Synthetic Tissue - Results Author Outcome LOE N Duration Adjunctive Augmentation mean (SD) % Giannini et al, 1994 Subjective Results- Excellent IV 15 18 months 100% Giannini et al, 1994 Return to Previous Activity IV 15 18 months 100% Rerupture IV 15 Healing Impairment IV 15 Giannini et al, 1994 Giannini et al, 1994 89 18 months 18 months 0% 0% v1.0 12.04.09 RECOMMENDATION 10 We cannot recommend for or against the use of antithrombotic treatment for patients with acute Achilles tendon ruptures. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: A systematic review was conducted to determine if prophylaxis for thromboembolic events is warranted for patients with acute Achilles tendon rupture. No studies were identified that address this issue. EXCLUDED STUDIES Table 107. Antithrombotic Treatment - Excluded Studies Author Title Nilsson-Helander, et al. 2009 High Incidence of deep venous thrombosis after Achilles tendon rupture: a prospective study Lapidus, et al. 2007 Prolonged thromboprophylaxis with dalteparin after surgical treatment of Achilles tendon rupture: a randomized, placebo-controlled study Lassen, et al. 2002 Exclusion Reason Not Relevant; Does not answer the recommendation. Less than 50% follow up Less than 80% Use of the low-molecular-weight heparin reviparin to prevent deepAchilles tendon tear vein thrombosis after leg injury requiring immobilization patients 90 v1.0 12.04.09 RECOMMENDATION 11 We suggest early (≤ 2 weeks) post-operative protected weight bearing (including limiting dorsiflexion) for patients with acute Achilles tendon rupture who have been treated operatively. AAOS Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. Rationale: A systematic review identified four Level II studies40, 5, 41,42 that compared early postoperative weight bearing to non-weight bearing following surgical repair of the Achilles tendon. All studies compared patients with either six weeks of non-weight bearing in a cast to early weight bearing. Two studies40, 42 permitted immediate weight bearing starting the day of surgery in a cast, defined as toe-touch weight bearing in one study.40 The second study5 allowed the weight bearing group to begin immediate rehabilitation on the first post-operative day in a modified splint. The patients in the third study41 began weight bearing two weeks after surgery. By two weeks, three investigators40, 5, 41 used a splint device that limited dorsiflexion to prevent compromise of the repair. After four weeks, Maffulli et al.40, 42 allowed the non-weight bearing group to begin full weight bearing in a cast, while the other two studies5, 41 kept the non-weight bearing group on crutches for six weeks. One study,5 found a significantly higher re-rupture rate in the early postoperative weight bearing group (2 of 23 patients) compared to non-weight bearing group (0 of 25 patients). Both patients had documented non-compliance with the use of their postoperative splint and fell during the first four weeks after surgery. Three studies40, 5, 42 found that the weight bearing group had statistical improvement in the time to return to activities including work, sports, and normal walking. Suchak et al.41 found significantly better scores in physical functioning and reported fewer limitations of daily living six weeks after the operation. By 12 months, all four studies found that there was no significant difference between the two groups in outcomes such as pain and function. Although the ultimate level of function achieved after operative repair of an Achilles rupture is similar regardless of the post-operative weight bearing protocol, early postoperative weight bearing allows the patient to achieve a quicker return to activities during the first six months than those patients treated with traditional postoperative casting. Treatment decisions should be made in light of all circumstances presented by the patient. 91 v1.0 12.04.09 Mutual communication between patient and physician should include a discussion of the importance of patient compliance when a program is prescribed for the use of early weight bearing. Patient compliance to protocol is important to prevent re-rupture. Supporting Evidence: Four Level II studies 40, 5, 41, 42 compare early postoperative weight bearing to non-weight bearing following surgical repair of the Achilles tendon. The post-operative regimes in the three studies are detailed in Table 108. For results of early weight bearing versus non-weight bearing see Table 109 through Table 115. Of forty-nine outcome measures comparing early weight bearing to non-weight bearing, seventeen were statistically significant in favor of early weight bearing, while one was in favor of non-weight bearing. Eleven of the seventeen results in favor of early weight bearing measured time until returning to activity (return to sports, return to normal walking, return to stair climbing, return to work, return to full weight bearing, number of physical therapy visits, and time until release from physical therapy) (see Table 109). A third study5 that measured time until return to work did not find a statistically significant difference between groups. At one and a half months, the early weight bearing group had no limitation and scored statistically significantly higher on the physical function, social function, vitality, and emotion components of the Rand-36 scale. One study reported that statistically significantly more patients returned to sports at 12 months (see Table 109).. However, two other studies reported no statistically significant difference in return to sports at six or twelve months. There was no statistically significant difference in pain, satisfaction, return to work, or footwear restrictions at twelve months (see Table 110 through Table 113). One study5, reported significantly more reruptures in the early weight bearing group. Of the two patients with re-ruptures, one patient did not follow the written rehabilitation protocol and the second patient suffered a fall on ice and forcibly dorsiflexed his ankle. There were no statistically significant differences between groups in complications. Table 108: Description of treatment groups Author Maffulli, et al.(a) Maffulli, et al (b) Costa, et al. Post operative Instructions Early weight bearing group: Bear weight on the tiptoes of the operated leg as tolerated but keep leg elevated for the first two weeks. Begin weight bearing as tolerated. Non-weight bearing group: No weight bearing and keep leg elevated for first two weeks. Increase weight bearing at 4 weeks. Early weight bearing group: Bear weight on the operated leg as tolerated but keep leg elevated for the first two weeks. Begin weight bearing as tolerated. Non-weight bearing group: No weight bearing and keep leg elevated for first two weeks. Increase weight bearing at 4 weeks. Early weight bearing group: Immediate weight bearing and mobilization using carbon fibre orthosis with 1.5 cm heal raises. 92 v1.0 12.04.09 Suchak, et al. Non-weight bearing group: Traditional plaster cast. Early weight bearing group: Two weeks of non-weight bearing followed by weight bearing. Non-weight bearing group: 6 weeks of non-weight bearing using auxiliary crutches. 93 v1.0 12.04.09 SUMMARY OF EVIDENCE Table 109 Time until return to activity Author Outcome LoE N Time to Return to Activity Maffulli, et al 2003 (a) Return to Sports (months) II 53 ●wb Maffulli, et al 2003 (b) Return to Sports (months) II 56‡ ●wb Costa, et al 2006 Return to Normal Walking (weeks) II 48‡‡ ●wb Costa, et al 2006 Return to Normal Stair Climbing (weeks) II 48‡‡ ●wb Costa, et al 2006 Return to Work (weeks) II 48‡‡ ○ Maffulli, et al 2003 (a) Return to Work (weeks) II 53 ●wb Maffulli, et al 2003 (a) Full weight bearing (wks) II 53 ●wb Maffulli, et al 2003 (b) Full weight bearing (wks) II 56‡ ●wb Maffulli, et al 2003 (a) Physiotherapy sessions (visits) II 53 ●wb Maffulli, et al 2003 (b) Physiotherapy sessions (visits) II 56‡ ●wb Maffulli, et al 2003 (a) Discharged from Physiotherapy (months) II 53 ●wb Maffulli, et al 2003 (b) Discharged from Physiotherapy (months) II 56‡ ●wb Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Number of patients is unclear. The authors state both 56 and 53 as the number of patients enrolled Table 110 Pain Result (months) Author Outcome LoE N Maffulli, et al 2003 (a) Pain- None II 53 ○‡ Maffulli, et al 2003 (a) Pain- Mild, Occasional II 53 ○‡ Maffulli, et al 2003 (a) Pain- Moderate II 53 ○‡ Maffulli, et al 2003 (b) Pain- None II 53 ○‡ 94 1.5 2 3 6 12 v1.0 12.04.09 Result (months) Author Outcome LoE N Maffulli, et al 2003 (b) Pain- Mild, Occasional II 53 ○‡ Maffulli, et al 2003 (b) II 53 ○‡ Pain- Moderate 1.5 2 3 6 12 Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks 95 v1.0 12.04.09 Table 111 Function Author Outcome Result (months) LoE N 1.5 ●wb 6 12 Suchak, et al 2008 Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Suchak, et al 2008 (a) Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) No Limitations or Limitations only in recreation II 110 No Limitations II 53 ○‡ No Limitations II 53 ○ 53 ○‡ 53 ○‡ Costa, et al 2006 Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Maffulli, et al 2003 (a) Maffulli, et al 2003 (b) Activity Limitation - Limited Recreational but not Daily Activities Activity Limitation - Limited Recreational but not Daily Activities II II ○‡ Return to at least partial sports II 38 Return to Sports II 48 ○‡ Return to Sports II 53 ○‡ Return to Sports II 48‡‡ ●wb Return to Work II 49 ○‡ Return to Work II 53 ○‡ Changed Jobs II 49 ○‡ ○‡ Changed Jobs Experience Problems at work due to injury Experience Problems at work due to injury Footwear restrictions- None, mild (most shoes tolerated) Footwear restrictions- None, mild (most shoes tolerated) Footwear restrictions- Moderate (unable to tolerate fashionable shoes, with or without insert) Footwear restrictions- Moderate (unable to tolerate fashionable shoes, with or without insert) 49 ○‡ 53 ○‡ II 53 ○‡ II 53 ○‡ II II 53 ○‡ II II ○‡ 53 Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference 96 v1.0 12.04.09 ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 112 EuroQoL, Rand-36 Author Outcome LoE N Costa, et al EuroQoL - Health II 48‡‡ 2006 Score Costa, et al EuroQoL - E5D II 48‡‡ 2006 Suchak, et al Rand-36 Physical II 110 2008 Functioning Suchak, et al Rand-36 Social II 110 2008 Functioning Suchak, et al Rand-36 Vitality II 110 2008 Suchak, et al Rand-36 RoleII 110 2008 Emotional Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Results (Months) 1.5 2 6 12 ○ ○ ○ ○ ○ ○ ●wb ●wb ●wb ●wb Table 113 Patient Subjective Results Author Maffulli, et al 2003 (a) Maffulli, et al 2003 (a) Maffulli, et al 2003 (a) Maffulli, et al 2003 (a) Outcome Patient opinion of resultsExcellent Percent satisfied with results of surgery Patient opinion of resultsExcellent Percent satisfied with results of surgery LoE N Results (Months) 12 months II 53 ○‡ II 53 ○‡ II 53 ○‡ II 53 ○‡ Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks 97 v1.0 12.04.09 Table 114 Reruptures Author LoE Duration N Weight Bearing Non-Weight Bearing Costa, et al II 1 year 48‡‡ 8.69% 0% 2006 ‡‡= Open cast group converted to orthosis at 3 weeks; ●‡ nwb= statistically significant difference in favor of non-weight bearing 98 Statistically Significant Difference ●‡ nwb v1.0 12.04.09 SUMMARY OF COMPLICATIONS Table 115 Reported Complications Author Suchak, et al 2008 Suchak, et al 2008 Suchak, et al 2008 NonStatistically Weight Significant Bearing Difference Complication LoE Duration N Weight Bearing DVT II 6 months 110 0% 2% ○‡ Necrosis of the skin II 6 months 110 0% 2% ○‡ Sural nerve dysesthesias, superficial infections, delayed wound healing, scar adhesions. II 6 months 110 15% 16% ○‡ Maffulli, Superficial et al II 12 months 53 7.69% 7.40% ○‡ Infection 2003 (a) Maffulli, Hypersensitivity et al of surgical II 10-12 wks 53 15.38% 18.51% ○‡ 2003 (a) wounds Maffulli, Hypertrophic et al II 10-12 weeks 53 3.84% 0% ○‡ Scar 2003 (a) Costa, et Minor wound II Nr 48‡‡ 26% 21% ○‡ al 2006 complications Costa, et Persistent II Nr 48‡‡ 0% 4.3% ○‡ al 2006 paraethesiae Maffulli, Hypersensitivity 12% 4% et al of surgical II 10-12 wks 53‡‡‡ ○‡ 2003 (b) wounds Maffulli, Hypertrophic 4% 4% et al II 10-12 weeks 53‡‡‡ ○‡ Scar 2003 (b) Wb= weight bearing Nwb= non-weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks ‡‡‡= Number of patients is unclear. The authors state both 56 and 53 as the number of patients enrolled 99 v1.0 12.04.09 Table 116 Systematic Reviews Author Conclusion Khan, RJK, et al. 2005 "Postoperative splinting in a cast followed by a functional brace rather than a cast alone reduces the overall complication rate" (p. 2209). Lynch, RM 2004 "Early functional mobilisation is more acceptable to patients than plaster cast immobilisation and results in improved functional outcomes" (p. 156). Suchak, AA et al. 2006 "An early functional rehabilitation protocol for Achilles tendon ruptures improves patient satisfaction with reduction in minor complications and no increase in rerupture rate or infection rate" (p. 220). 100 v1.0 12.04.09 EXCLUDED ARTICLES Table 117 Article Inclusion List- Early weight bearing vs. non-weight bearing Author Title Exclusion Reason Costa, et al. 2003 Wagnon, et al. 2005 Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures: a functional and MRI assessment Less than 10 patients per group Aoki, et al. 1998 Early active motion and weight bearing after crossstitch Achilles tendon repair Speck, et al. 1998 Early full weight bearing and functional treatment after surgical repair of acute Achilles tendon rupture Solveborn, et al. 1994 Immediate free ankle motion after surgical repair of acute Achilles tendon ruptures 101 No patient-oriented outcome Not best available evidence - not comparative Not best available evidence - not comparative Not best available evidence - not comparative v1.0 12.04.09 Treatment(s) LoE Allocation Concealment Patients Blinded N Stochastic Randomization Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at baseline STUDY QUALITY Table 118. Quality- Weight bearing vs. non-weight bearing- RCT II ● ● × × ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome Costa, et al. 2006 Return to Sports 43 Weight bearing vs. Non-weight bearing Costa, et al. 2006 Return to Sport (weeks) ‡‡ 43 Weight bearing vs. Non-weight bearing II ● ● × × ● ● Costa, et al. 2006 Return to Normal Walking (weeks) 43 Weight bearing vs. Non-weight bearing II ● ● × × ● ● Costa, et al. 2006 Return to Normal Stair Climbing (weeks) 43 Weight bearing vs. Non-weight bearing II ● ● × × ● ● Costa, et al. 2006 Return to Work (weeks) 43 Weight bearing vs. Non-weight bearing II ● ● × × ● ● Costa, et al. 2006 EuroQoL - Health Score‡‡ 43 Weight bearing vs. Non-weight bearing II ● ● × × ● × Costa, et al. 2006 EuroQoL - E5D‡ 43 Weight bearing vs. Non-weight bearing II ● ● × × ● × 102 v1.0 12.04.09 Outcome N Treatment(s) LoE Stochastic Randomization Allocation Concealment Patients Blinded Author Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at baseline Suchak, et al. 2008 RAND-36: Physical Function 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 RAND-36: Mental health 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 Complications 110 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 RAND-36: Social Functioning 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 RAND-36: Rolephysical 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 RAND-36: Bodily pain 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 RAND-36: General health 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × Suchak, et al. 2008 RAND-36: Vitality 109 Weight bearing vs. Non-weight bearing II ● ● × × ● × ● = Yes ○ = No × = Not Reported n/a = not applicable 103 v1.0 12.04.09 Suchak, et al. 2008 RAND-36: Roleemotional 109 Weight bearing vs. Non-weight bearing II 104 All groups have similar outcome performance at baseline LoE Follow Up - 80% or more Treatment(s) Those rating outcome Blinded N Patients Blinded Outcome Allocation Concealment Author Stochastic Randomization ● = Yes ○ = No × = Not Reported n/a = not applicable ● ● × × ● × v1.0 12.04.09 All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data Table 119. Quality- Weight bearing vs. non-weight bearing- Comparative II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome N Maffulli, et al. 2003 (a) Pain- None 53 Maffulli, et al. 2003 (a) Pain- Mild, Occasional 53 Maffulli, et al. 2003 (a) Pain- Moderate 53 Maffulli, et al. 2003 (a) Return to Sports 53 Maffulli, et al. 2003 (a) Return to Sports (months) 53 Maffulli, et al. 2003 (a) Return to Work (weeks) 53 Treatment(s) Weight Bearing vs. Non-Weight Bearing Weight Bearing vs. Non-Weight Bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing 105 LoE v1.0 12.04.09 All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● Weight Bearing vs. Non Weight II ● ● x ● ● Weight Bearing vs. Non-weight bearing II ● ● x ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome N Maffulli, et al. 2003 (a) Return to Work 53 Maffulli, et al. 2003(a) Changed Jobs 53 Maffulli, et al. 2003 (a) Experience Problems at work due to injury 53 Maffulli, et al. 2003 (a) Full weight bearing (wks) 53 Maffulli, et al. 2003 (a) Activity Limitation - None 53 Maffulli, et al. 2003(a) Activity Limitation - Limited Recreational but not Daily Activities 53 Maffulli, et al. 2003 (a) Discharged from Physiotherapy (months) 53 Treatment(s) Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing 106 LoE v1.0 12.04.09 All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome Maffulli, et al. 2003 (a) Physiotherapy sessions (visits) Maffulli, et al. 2003 (a) Maffulli, et al. 2003 (a) Footwear restrictions- None, mild (most shoes tolerated) Footwear restrictionsModerate (unable to tolerate fashionable shoes, with or without insert) N 53 53 53 Maffulli, et al. 2003 (a) Percent satisfied with results of surgery 53 Maffulli, et al. 2003 (a) Patient opinion of results- Excellent 53 Maffulli, et al. 2003 (b) Pain- None 53 Treatment(s) Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non Weight Bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-Weight Bearing 107 LoE v1.0 12.04.09 All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome N Maffulli, et al. 2003 (b) Pain- Mild, Occasional 53 Maffulli, et al. 2003 (b) Pain- Moderate 53 Maffulli, et al. 2003 (b) Return to Sports 53 Maffulli, et al. 2003 (b) Return to Sports (months) 53 Maffulli, et al. 2003 (b) Return to Work (weeks) 51 Maffulli, et al. 2003 (b) Return to Work 51 Maffulli, et al. 2003(b) Changed Jobs 51 Treatment(s) Weight Bearing vs. Non-Weight Bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing 108 LoE v1.0 12.04.09 All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more Same center for experimental and control group data II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome N Maffulli, et al. 2003 (b) Experience Problems at work due to injury 51 Maffulli, et al. 2003 (b) Full weight bearing (wks) 56‡‡ Maffulli, et al. 2003 (b) Activity Limitation - None 53 Maffulli, et al. 2003(b) Activity Limitation - Limited Recreational but not Daily Activities 53 Maffulli, et al. 2003 (b) Discharged from Physiotherapy (months) 56‡‡ Maffulli, et al. 2003 (b) Physiotherapy sessions (visits) 56‡‡ Maffulli, et al. 2003 (b) Footwear restrictions- None, mild (most shoes tolerated) 53 Treatment(s) Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non Weight Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non Weight Bearing 109 LoE v1.0 12.04.09 Treatment(s) LoE All groups have similar characteristics at entry All groups have similar outcome performance at entry All groups concurrently treated Follow Up - 80% or more N Same center for experimental and control group data 53 Weight Bearing vs. Non-weight bearing II ● ● x ● ● II ● ● x ● ● II ● ● x ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Outcome Maffulli, et al. 2003 (b) Footwear restrictionsModerate (unable to tolerate fashionable shoes, with or without insert) Maffulli, et al. 2003 (b) Percent satisfied with results of surgery 53 Maffulli, et al. 2003 (b) Patient opinion of results- Excellent 53 Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing 110 v1.0 12.04.09 STUDY RESULTS Table 120 Study Data: Weight Bearing vs. Non-Weight Bearing Weight Non-Weight Bearing Bearing Result 110 61.4 (SD 29.4) 47.6 (SD 34.4) p = 0.03 6 week 110 72.7 (SD 28.5) 60.7 (SD 26.8) p = 0.03 II 6 week 110 69.4 (SD 23.7) 60.6 (SD 21.1) p = 0.04 II 6 week 110 84.6 (SD 32.0) 67.3 (SD 43.1) p = 0.02 No Limitations or Suchak, et al Limitations only in 2008 recreation II 6 week 110 43% 9% p = <.001 Suchak, et al 2008 II 6 months 110 67% 63% p=0.68 Author Outcome Suchak, et al 2008 Rand-36 Physical Functioning II 6 week Suchak, et al 2008 Rand-36 Social Functioning II Suchak, et al 2008 Rand-36 Vitality Suchak, et al 2008 Rand-36 RoleEmotional Return to at least partial sports LoE Duration N Maffulli, et al Full weight bearing 2003(a) (wks) II 12 months 53 2.5 (SD 0.4) 5.5 (SD 2.2) p = 0.021 Maffulli, et al 2003(a) Physiotherapy sessions (visits) II 12 months 53 6.1 (SD 3.1) 13.6 (SD 4.8) p = 0.03 Maffulli, et al 2003(a) Discharged from Physiotherapy (months) II 12 months 53 2.1 (SD 1.1) 4.6 (SD 2) p = <.0001 Maffulli, et al 2003(a) Pain- None II 12 months 53 88% 89% p= 0.96 ‡ Maffulli, et al 2003(a) Pain- Mild, Occasional II 12 months 53 8% 7% p=0.97‡ Maffulli, et al 2003(a) Pain- Moderate II 12 months 53 4% 4% p=0.98 ‡ Maffulli, et al Activity Limitation 2003(a) None II 12 months 53 92% 93% p=0.97‡ Activity Limitation Maffulli, et al Limited Recreational 2003(a) but not Daily Activities II 12 months 53 8% 7% p=0.97 111 v1.0 12.04.09 LoE Duration N Weight Non-Weight Bearing Bearing Author Outcome Maffulli, et al 2003(a) Return to Sports II 12 months 38 89% 89% p=0.99 ‡ Maffulli, et al 2003(a) Return to Sports (months) II 12 months 53 5.1 (SD 2.8) 6 (SD 3) p= 0.04 12 months 53 96% 93% p=0.57‡ 12 months 53 4% 7% p=0.57‡ Footwear restrictionsNone, mild (most II shoes tolerated) Footwear restrictionsModerate (unable to Maffulli, et al tolerate fashionable II 2003(a) shoes, with or without insert) Maffulli, et al 2003(a) Result Maffulli, et al Percent satisfied with 2003(a) results of surgery II 12 months 53 88% 85% p=0.51‡ Maffulli, et al 2003(a) Excellent II 12 months 53 88% 81% p=0.47‡ Maffulli, et al 2003(a) Return to Work (weeks) II 12 months 53 9.2 (SD 2.5) 13.2 (SD 3) p= 0.05 Maffulli, et al 2003(a) Return to Work II 12 months 49 100% 100% 1 Maffulli, et al 2003(a) Changed Jobs II 12 months 49 1 2 p=0.51‡ Maffulli, et al Experience Problems 2003(a) at work due to injury II 12 months 49 2 4 .p=0.41‡ Maffulli, et al Full weight bearing 2003 (b) (wks) II 6 weeks 53‡‡ ‡ 2.5 (SD 0.4) 5.7 (SD 2.2) P=0.013 Maffulli, et al 2003 (b) Physiotherapy sessions (visits) II 12 53‡‡ months ‡ 8.3 (SD 4.1) 14.6 (SD 5.3) p = 0.008 Maffulli, et al 2003(b) Discharged from Physiotherapy (months) II 12 months 53‡ 2.7 (SD 1.1) 4.7 (SD 2) <.08 Maffulli, et al 2003(b) Pain- None II 12 months 53 92% 86% P=0.46‡ Costa, et al 2006 Return to Sports II 1 year 48‡‡ 83% 68% p= 0.04 112 v1.0 12.04.09 Weight Non-Weight Bearing Bearing Result 48‡‡ 12.5 (CI 18 (CI 18-22) 10-18) p= 0.03 1 year 48‡‡ 13 (CI 1022 (CI 18-22) 18) p= 0.02 1 year 48‡‡ 8 (CI 2-13) 4(CI 1-13) Author Outcome Costa, et al 2006 Return to Normal Walking (weeks) II 1 year Costa, et al 2006 Return to Normal Stair Climbing (weeks) II Costa, et al 2006 Return to Work (weeks) II Costa, et al 2006 EuroQoL - Health Score II 2 months 48‡‡ 75 (IQR 70-85) 75 (IQR 6580) p= 0.85 Costa, et al 2006 EuroQoL - Health Score II 6 months 48‡‡ 85 (IQR 80-90) 81 (IQR 7595) p= 0.96 Costa, et al 2006 EuroQoL - Health Score‡‡ II 84 (IQR 75-95) 90 (IQR 8595) p= 0.14 Costa, et al 2006 EuroQoL - E5D II 2 months 48‡‡ 0.69 (IQR 0.6-0.9) 0.69 (IQR 0.6-0.7) p= 0.45 Costa, et al 2006 EuroQoL - E5D II 6 months 48‡‡ 0.8 (IQR 0.8 (IQR 0.80.7-1.0) 1.0) p= 0.96 Costa, et al 2006 EuroQoL - E5D II 1 year 48‡‡ 1 (IQR 0.9-1.0) 1(IQR 0.81.0) p= 0.15 Costa, et al 2006 Re-rupture II 1 year 48‡‡ 8.69% 0 p= 0.03‡ Suchak, et al 2008 DVT II 6 months 110 0 2% p= 0.14‡ Suchak, et al Necrosis of the skin 2008 II 6 months 110 0 2% p= 0.14‡ Sural nerve dysesthesias, Suchak, et al superficial infections, 2008 delayed wound healing, scar adhesions. II 6 months 110 15% 16% p= 0.89‡ Maffulli, et al Superficial Infection 2003(a) II 12 months 53 7.69% 7.40% p= 0.97‡ II Nr 48‡‡ 26% 21% p=0.17‡ Costa, et al 2006 Minor wound complications LoE Duration N 1 year 113 48‡‡ p= 0.59 v1.0 12.04.09 Author Outcome Costa, et al 2006 Persistent paraethesiae LoE Duration N Weight Non-Weight Bearing Bearing Result II Nr 48‡‡ 0% 4.3% p= 0.60‡ Maffulli, et al Hypersensitivity of 2003(a) surgical wounds II 10-12 wks 53 15.38% 18.51% p= 0.76‡ Maffulli, et al Hypertrophic Scar 2003(a) II 10-12 weeks 53 3.84% 0% p= 0.15‡ Maffulli, et al 2003 (b) Pain- Mild, Occasional II 12 months 53 8% 8% p=0.93 Maffulli, et al 2003 (b) Pain- Moderate II 12 months 53 0% 7% p=0.95 Maffulli, et al Activity Limitation 2003 (b) None II 12 months 53 0.96 89% p=0.37 Activity Limitation Maffulli, et al Limited Recreational 2003 (b) but not Daily Activities II 12 months 53 4% 11% p=0.91 Maffulli, et al 2003 (b) II 12 months 53‡ 89% 89% p=0.93 II 12 53‡‡ 5.2 (SD 3) 6.1 (SD 2.8) months ‡ p=0.45 12 months 53 96% 96% p=0.33 12 months 53 4% 4% p=0.97 Return to Sports Maffulli, et al Time until Return to 2003 (b) Sports (months) Footwear restrictionsNone, mild (most II shoes tolerated) Footwear restrictionsModerate (unable to Maffulli, et al tolerate fashionable II 2003 (b) shoes, with or without insert) Maffulli, et al 2003 (b) Maffulli, et al Percent satisfied with 2003 (b) results of surgery II 12 months 53 84% 89% p=0.37 Maffulli, et al 2003 (b) Excellent II 12 months 53 84% 89% p=0.37 Maffulli, et al 2003 (b) Return to Work II 12 months 51 100% 100% 1 Maffulli, et al 2003 (b) Changed Jobs II 12 months 49 1 2 p=0.61 114 v1.0 12.04.09 Author Outcome LoE Duration N Weight Non-Weight Bearing Bearing Result Maffulli, et al Experience Problems 2003 (b) at work due to injury II 12 months 49 20% 11% p=0.91 Maffulli, et al Hypersensitivity of 2003 (b) the surgical wound II 6 weeks 53 12% 4% p=0.97 Maffulli, et al Hypertrophic scar 2003 (b) II 6 weeks 53 4% 4% p=0.97 ‡= AAOS calculations 115 v1.0 12.04.09 RECOMMENDATION 12 We suggest the use of a protective device that allows mobilization by 2- 4 weeks post operatively. AAOS Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. Rationale: A systematic review identified five Level II 40, 43-45 studies comparing postoperative immobilization to postoperative mobilization following surgical repair of the Achilles tendon. All five studies randomized the patients into two groups with either six weeks in a cast or early motion with a modified splint device. For all studies, patients in the mobilization group had a splint or modified cast device that limited dorsiflexion to protect the repair. All five studies40, 5, 43-45 found that the weight bearing group had statistical improvement in the mean time to return to activities such as work and normal walking. One44 of three studies found a significantly higher rate in return to sport activities at twelve months, while two40, 39 found no difference. One study 5 found a significantly higher re-rupture rate in the postoperative mobilization group (2 of 23 patients) compared to the immobilization group (0 of 25 patients). Both patients had documented non-compliance with the use of their postoperative splint and fell during the first 4 weeks after surgery. By 12 to 18 months, all five studies40, 5, 43-45 found that there was no significant difference between the two groups in outcomes such as pain and function. Although the ultimate level of function achieved after operative repair of an Achilles rupture is similar regardless of the postoperative immobilization protocol, early postoperative mobilization allows the patient to achieve a quicker return to activities during the first six months than those patients treated with immobilization. However, treatment decisions should be made in light of all circumstances presented by the patient. Mutual communication between patient and physician should include a discussion of the importance of patient compliance when a program is prescribed for early mobilization. Patient compliance to protocol is important to aid in protection of the incision during the early post-operative period and is also important to prevent wound healing complications. Supporting Evidence Five Level II studies40, 5, 43-45 compare postoperative immobilization to postoperative mobilization. The post operative mobilization and immobilization regimes are detailed in 116 v1.0 12.04.09 Table 121. Please see Table 122 through Table 129 for results of mobilization versus immobilization. Of the forty outcomes reported, seventeen were statistically significant in favor of early motion. Nine of the seventeen statistically significant results measured time until return to activity, sports, walking, stair climbing, work, weight bearing, discharge from physiotherapy, number of physiotherapy sessions, and sick leave (see Table 122). However, another study that reported time until return to sport and work did statistically significantly differ between groups (see Table 122). Patients in the early motion group reported statistically significantly less pain at one month but no statistically significant difference in pain at three, six, or twelve months (see Table 123). One of seven outcome measures found a statistically significant difference in the percent of patients able to return to sports in favor of the motion group. Statistically significantly more patients were able to stand on their toes and walk as far as they could before surgery in the early motion group at three and six months. Patients in the early motion group were more satisfied with their cast at one year. There was no statistically significant difference between groups in regard to: patient opinion of results, footwear restrictions, EuroQoL, E5D, or Ankle Performance Score (see Table 124). Costa, et al5, reported significantly more re-ruptures in the early weight bearing group. Of the two patients with re-ruptures, one patient did not follow the written rehabilitation protocol and the second patients suffered a fall on ice and forcibly dorsiflexed his ankle. Abnormal sensibility was significantly more prevalent in the immobilized group than in the motion group. There were no other statistically significant differences between groups in complications. Table 121. Description of Treatment Groups Author Costa, et al. Mortensen, et al. Cetti, et al. Kangas, et al Maffulli, et al. (a) Post operative Instructions Mobilization group: Immediate weight bearing and mobilization using carbon fibre orthosis with 1.5 cm heal raises. Immobilization group: Traditional plaster cast. Mobilization group: Below the knee dorsal plaster splint followed by walker brace. Immobilization group: Below the knee plaster cast Mobilization group. Mobile cast Immobilization group. Rigid below the knee cast Mobilization group. Below the knee dorsal cast for 6 weeks, this allowed for free plantar flexion. Immobilization group. Below the knee plaster cast Mobilization group: Removable splint and mobilization at 2 weeks. Immobilization group: Below the knee plaster cast. SUMMARY OF EVIDENCE Table 122. Time to Return to Activity 117 v1.0 12.04.09 Author Maffulli, et al 2003(a) Costa, et al 2005 Cetti, et al. 1994 Costa, et al 2005 Costa, et al 2005 Costa, et al 2005 Cetti, et al. 1994 Maffulli, et al 2003(a) Maffulli, et al 2003(a) Outcome Return to Sports (months) Time in weeks taken to return to sport Return to same level of sports activities Time in weeks until return to stair climbing Time in weeks taken to return to walking Time in weeks taken to return to work. LoE II Comparison Early Motion vs. Immobilization Time to return 53 ●em II Early Motion vs. Cast 48‡‡ ○ II Early Motion vs. Cast 60 ●em II Early Motion vs. Cast 48‡‡ ●em II Early Motion vs. Cast 48‡‡ ●em II Early Motion vs. Cast 48‡‡ ○ 60 ●em 53 ●em 53 ●em 53 ●em 53 ●em Mean Sick leave (days) II Return to Work (weeks) II Full weight bearing (wks) II Early Motion vs. Cast Early Motion Vs. Immobilization Early Motion Vs. Immobilization Early Motion Vs. Immobilization Physiotherapy sessions II (visits) Discharged Early Motion Maffulli, from II Vs. et al 2003 Physiotherapy Immobilization (months) em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Maffulli, et al 2003 N 118 v1.0 12.04.09 Table 123. Pain Author Outcome LoE Comparison N 1 Kangas, et al 2002 Vas Pain II Maffulli, et al 2003 Pain- None II Maffulli, et al 2003 Pain- Mild, Occasional II Maffulli, et al 2003 Pain- Moderate II Early Motion vs. Cast ●em 50 Early Motion vs. Immobilization Early Motion Vs. Immobilization Early Motion Vs. Immobilization Duration (Months) 3 6 ○ 12 ○ 53 ○ 53 ○ 53 ○ em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 124. Function Author Outcome LoE Comparison N 3 Costa, et al 2005 Return to sports II Mortensen, et al 1999 Return to sports II Maffulli, et al 2003 Return to Sports II Cetti, et al. 1994 Mortensen, et al 1999 Cetti, et al. 1994 Cetti, et al. 1994 Return sports activities Reached pre-injury level Return to lesser level of sports activities Stopped sports activities II II Early Motion vs. Cast Early Motion vs. Cast Early Motion vs. Immobilization Early Motion vs. Cast Early Motion vs. Cast 48 ‡‡ Duration (Months) 6 12 ○ ○ 61 38 ○ 60 ●e m ○ 61 II Early Motion vs. Cast 60 ○ II Early Motion vs. Cast 60 ○ 119 18 v1.0 12.04.09 Author Outcome Duration (Months) 6 12 LoE Comparison N II Early Motion Vs. Immobilization 53 ○ II Early Motion Vs. Immobilization 53 ○ II Early Motion vs. Cast 71 ●em 60 ●em 3 Maffulli, et al 2003 Maffulli, et al 2003 Mortensen, et al 1999 Cetti, et al. 1994 No Limitations Activity Limitation - Limited Recreation al but not Daily Activities Able to walk as far before surgery Able to stand on toes II Early Motion vs. Cast Early Motion vs. Cast ●em 18 ○ Mortensen, et al 1999 Sick Leave (days) II Maffulli, et al 2003 Return to Work II 49 ○ Maffulli, et al 2003 Changed Jobs II 49 ○ ●em em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 125. EuroQoL, E5D, Ankle Performance Score Duration (Months) Author Outcome Costa, et al 2006 EuroQoL Health Score‡‡ Costa, et al 2006 E5D (Dimension of Health LoE Comparison N 3.5 Early Motion II 48‡‡ ○ vs. Cast Early II Motion 48‡‡ ○ vs. 120 4 12 ○ ○ ○ ○ 15 v1.0 12.04.09 Score) Cast Ankle Early Performance Motion II 50 Score vs. Excellent Cast em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Kangas, et al 2002 ○ Table 126. Patient opinion of results Author Cetti, et al. 1994 Mortensen, et al. 1999 Cetti, et al. 1994 Outcome Patient opinion of castexcellent Subjective ResultExcellent Complaints LoE 3m 6m 12m 16m II ●em ●em II II ●em Patient opinion of resultsII Excellent Percent satisfied Maffulli, et with results of II al 2003 surgery em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Maffulli, et al 2003 121 ○ ●em ○ ○ v1.0 12.04.09 Table 127. Footwear restrictions Duration (Months) Author Kangas, et al 2002 Outcome LoE Footwear Restrictions II Comparison Early Motion vs. Cast Footwear restrictionsEarly Motion None, mild II vs. (most shoes Cast tolerated) Footwear restrictionsModerate Maffulli, Early Motion (unable to et al II vs. tolerate 2003 Cast fashionable shoes, with or without insert) em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Maffulli, et al 2003 N 12 16 ○ 50 53 ○ 53 ○ Table 128. Rerupture Author LoE Duration N Early Motion Cetti, et al. ReII 3% 1994 rupture Costa, et al 48 II 1 year 8.69% 2006 ‡‡ em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks 122 Immobilizatio n Statistically Significant Difference 7% ○ 0% ●‡ nwb v1.0 12.04.09 SUMMARY OF COMPLICATIONS Table 129. Early Motion vs. Cast - Complications Rigid Cast Group Statistically Significant Difference Author Complication LoE N Early Motion Cetti, et al. 1994 Infection II 60 0% 3% ○ Cetti, et al. 1994 Scar Adhesion II 60 3% 13% ○ Cetti, et al. 1994 Suture Granuloma II 60 3% 0% ○ Cetti, et al. 1994 Abnormal Sensibility II 60 3% 17% ●em Cetti, et al. 1994 Keloid Scar II 60 10% 23% ○ Cetti, et al. 1994 Re-rupture II 60 3% 7% ○ Mortensen Deep Infection II 61 3% 0% ○ Mortensen Failed Repair II 61 3% 7% ○ 60 23% 20% ○ 53 7.69% 7.40% ○ 53 15.38% 18.51% ○ 53 3.84% 0% ○ Costa, et al Minor Wound II 2006 Complications Maffulli, et al Superficial II 2003 Infection Maffulli, et al Hypersensitivity II 2003 of surgical wounds Maffulli, et al Hypertrophic Scar II 2003 em= early motion nem= not early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculated 123 v1.0 12.04.09 Table 130. Systematic Reviews Author Khan, RJK, et al. 2005 Lynch, RM 2004 Suchak, AA et al. 2006 Conclusion "Postoperative splinting in a cast followed by a functional brace rather than a cast alone reduces the overall complication rate" (p. 2209). "Early functional mobilisation is more acceptable to patients than plaster cast immobilisation and results in improved functional outcomes" (p. 156). "An early functional rehabilitation protocol for Achilles tendon ruptures improves patient satisfaction with reduction in minor complications and no increase in rerupture rate or infection rate" (p. 220). 124 v1.0 12.04.09 EXCLUDED ARTICLES Table 131. Mobilization vs. Immobilization Included Articles Author Title Maffulli N;Tallon C;Wong J;Lim KP;Bleakney R; Kangas J;Pajala A;Ohtonen P;Leppilahti J; Majewski M;Schaeren S;Kohlhaas U;Ochsner PE; Achilles tendon rupture: effect of early mobilization in rehabilitation after surgical repair Percutaneous repair of Achilles tendon rupture. Immobilization versus functional postoperative treatment Functional treatment after surgical repair of acute Achilles tendon rupture: wrap vs. walking cast Recovering motor performance of the foot after Achilles rupture repair: a randomized clinical study about early functional treatment vs. early immobilization of Achilles tendon in tension Early weight bearing and ankle mobilization after open repair of acute midsubstance tears of the Achilles tendon Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative regimens Postoperative rehabilitation after percutaneous Achilles tendon repair: Early functional therapy versus cast immobilization Solveborn SA;Moberg A; Immediate free ankle motion after surgical repair of acute Achilles tendon ruptures Sorrenti SJ; Buchgraber A;Passler HH; Kerkhoffs GM;Struijs PA;Raaymakers EL;Marti RK; Kauranen K;Kangas J;Leppilahti J; 125 Exclusion Reason Not relevant Not best available evidence Not relevant No patient oriented outcome Not relevant Duplicate - Data reported in prior study Not best available evidence Not best available evidence - not comparative v1.0 12.04.09 Stochastic Randomization Allocation Concealment Patients Blinded Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry STUDY QUALITY Table 132. Mobilization vs. Immobilization Quality II ● ● × × ● × II ● ● × × ● × II ● ● × × ● × II ● ● × × ● × II × ● ○ ○ ● ● II × ● ○ ○ ● ● II × ● ○ ○ ● ● II × ● ○ ○ ● ● II × ● ○ ○ ● ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Costa, et al. 2006 Costa, et al. 2006 Costa, et al. 2006 Costa, et al. 2006 Kangas, et al. 2003 Kangas, et al. 2003 Kangas, et al. 2003 Kangas, et al. 2003 Kangas, et al. 2003 Outcome N Sport 43 Walking 43 Stair Climbing 43 Work 43 VAS Pain 50 VAS Pain 50 VAS Pain 50 VAS Pain 50 VAS Pain 50 Treatment(s) LoE Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization 126 v1.0 12.04.09 Outcome N Stochastic Randomization Allocation Concealment Patients Blinded Those rating outcome Blinded Follow Up - 80% or more All groups have similar outcome performance at entry Kangas, et al. 2003 Stiffness Mobilization 50 vs. Immobilization II × ● ○ ○ ● ● Kangas, et al. 2003 subjective calf muscle weakness 50 Mobilization vs. Immobilization II × ● ○ ○ ● ● footwear restrictions 50 II × ● ○ ○ ● ● Ankle performance score 50 II × ● ○ ○ ● ● Sick Leave 61 II ● ○ ○ ○ ○ ● Subjective assessment 61 II ● ○ ○ ○ ○ ● Sports Activity 61 II ● ○ ○ ○ ○ ● Pain 61 II ● ○ ○ ○ ○ ● ● = Yes ○ = No × = Not Reported n/a = not applicable Author Kangas, et al. 2003 Kangas, et al. 2003 Mortensen, et al. 1999 Mortensen, et al. 1999 Mortensen, et al. 1999 Mortensen, et al. 1999 Treatment(s) Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization 127 LoE v1.0 12.04.09 N Mortense n, et al. 1999 Stiffness 61 Mortense n, et al. 1999 Able to walk as far as pre surgery 61 Cetti, et al. 1994 Resumption of sports activity 111 Cetti, et al. 1993 Return to sport 111 Cetti, et al. 1993 Return to work 111 Cetti, et al. 1993 Re-rupture 111 Maffulli, et al. 2003 Pain- None 53 Pain- Mild, Occasional 53 Pain- Moderate 53 Return to Sports 53 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Treatment(s) Mobilization vs. Immobilizatio n Mobilization vs. Immobilizatio n Mobilization vs. Immobilizatio n Mobilization vs. Immobilizatio n Mobilization vs. Immobilizatio n Mobilization vs. Immobilizatio n Mobilization vs. Immobilizatio n Mobilization vs. Immobilization Mobilization vs. Immobilization Mobilization vs. Immobilization ● ○ ○ ○ ○ ● II ● ○ ○ ○ ○ ● II × × × × × ○ II × × ○ ● ● ● II × × ○ ● ● ● II × × ○ ● ● ● II ○ ○ ○ ● ● × II ○ ○ ○ ● ● × II ○ ○ × × ● × II ○ ○ × × ● × 128 LoE v1.0 12.04.09 All groups have similar outcome performance at entry Patients Blinded Outcome Follow Up - 80% or more Allocation Concealment Author Those rating outcome Blinded Stochastic Randomization II ● = Yes ○ = No × = Not Reported n/a = not applicable N Maffulli, et al. 2003 Return to Sports (months) 53 Maffulli, et al. 2003 Return to Work (weeks) 53 Return to Work 53 Changed Jobs 53 Experience Problems at work due to injury 53 Full weight bearing (wks) 53 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Activity Limitation None Activity Limitation Limited Recreational but not Daily Activities Discharged from Physiotherapy (months) 53 Treatment(s) Mobilization vs. Immobilization Mobilization vs. Immobilizatio n Mobilization vs. Immobilization Mobilization vs. Immobilization ○ ○ × × ● ● II ○ ○ × × ● ● II ○ ○ × × ● ● II ○ ○ × × ● ● Mobilization vs. Immobilization II ○ ○ × × ● ● Mobilization vs. Immobilization Mobilization vs. Immobilization II ○ ○ × × ● ● II ○ ○ × × ● ● LoE All groups have similar outcome performance at entry Patients Blinded Outcome Follow Up - 80% or more Allocation Concealment Author Those rating outcome Blinded Stochastic Randomization II ● = Yes ○ = No × = Not Reported n/a = not applicable 53 Mobilization vs. Immobilization II ○ ○ × × ● ● 53 Mobilization vs. Immobilization II ○ ○ × × ● ● II ○ ○ × × ● ● II ○ ○ × × ● ● Physiotherapy sessions (visits) 53 Footwear restrictionsNone, mild 53 Mobilization vs. Immobilization Mobilization vs. Immobilization 129 v1.0 12.04.09 Maffulli, et al. 2003 Maffulli, et al. 2003 Footwear restrictionsModerate (unable to tolerate fashionable shoes) Percent satisfied with results of surgery Patient opinion of resultsExcellent N Treatment(s) 53 Mobilization vs. Immobilization ○ ○ × × ● ● 53 53 Weight Bearing vs. Non-weight bearing Weight Bearing vs. Non-weight bearing II ○ ○ × × ● ● II ○ ○ × × ● ● 130 LoE v1.0 12.04.09 All groups have similar outcome performance at entry Patients Blinded Maffulli, et al. 2003 Outcome Follow Up - 80% or more Allocation Concealment Author Those rating outcome Blinded Stochastic Randomization II ● = Yes ○ = No × = Not Reported n/a = not applicable STUDY RESULTS Table 133. Mobilization vs. Immobilization Study Data Author Cetti, et al. 1994 Cetti, et al. 1994 Outcome Return to same level of sports activities Return to lesser level of sports activities Stopped sports activities Patient opinion of cast- excellent Cetti, et al. 1994 Mean Sick leave (days) Cetti, et al. 1994 Cetti, et al. 1994 Results Early Motion Cast LoE Duration N II 1 year 60 80% 50% p= 0.0292 II 1 year 60 7% 13% p= 0.616 II 1 year 60 3% 13% p= 0.141 II 1 year 60 77% 20% p= 0.0005 II NA 60 20.2 (Range 3-75) 53.4 (Range 1-182) p= 0.0009 60 83% 53% p= 0.025 60 100% 77% p= 0.011 60 100% 97% p= 0.15‡ 60 3% 7% p= 0.55‡ 60 17.0 25.00 p= 0.047 60 10.00 14.00 p= 0.290‡ 60 3.00 11.00 p= 0.03 61 19% 40% p= 0.06 61 84% 63% p=0.06‡ 61 73% 76% OR =1 Cetti, et al. Able to stand on II 3 months 1994 toes Cetti, et al. Able to stand on II 6 months 1994 toes Cetti, et al. Able to stand on 12 II 1994 toes months Cetti, et al. Re-rupture II NA 1994 Cetti, et al. Complaints II 3 months 1994 Cetti, et al. Complaints II 6 months 1994 Cetti, et al. 12 Complaints II 1994 months Mortensen, Able to walk as far et al as they could II 12 weeks 1999 before surgery Mortensen, Subjective Result 16 et al II excellent months 1999 Mortensen, 16 et al Returned to sports II months 1999 ‡= AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks 131 Results v1.0 12.04.09 Results Author Outcome LoE Duration N Early Motion Cast Results Mortensen, et al 1999 Reached preinjury level II 16 months 61 57% 55% 1 Mortensen, et al 1999 Time until preinjury level reached (months) II NA 61 6 (2.5-13) 9 (6-14) P <0.01 Vas Pain II 1 week 50 2.17± 2.7 2.02 ± 1.7 p= 0.08 Vas Pain II 3 weeks 50 .83 ± 1.2 .82 ± 1.3 p= 0.797 Vas Pain II 6 weeks 50 .65 ± 1.4 .60 ± .09 p= 0.9 No Stiffness II 60 weeks 50 44% 68% p>0.08 Mild Stiffness II 60 weeks 50 56% 32% p>0.08 No footwear restrictions II 60 weeks 50 68% 92% p>0.08 Ankle Performance Score - Excellent II 60 weeks 50 88% 92% p>0.08 Re-rupture II 5 months 50 4% 8% 1.000 48 18 (95% CI 1222) Kangas, et al 2002 Kangas, et al 2003 Kangas, et al 2003 Kangas, et al 2003 Kangas, et al 2003 Kangas, et al 2003 Kangas, et al 2003 Kangas, et al 2003 18 (95% CI 1822) 18 (95% CI 1422) Costa, et al 2006 Return to Normal Walking‡‡ II Time measurement Costa, et al 2006 Return to Normal Stair Climbing‡‡ II Time measurement 48 17 (95% CI 1118) Cetti, et al. 1994 Infection II Not Reported 60 0 3.3 p= 0.155‡ Cetti, et al. 1994 Scar Adhesion II Not Reported 60 3.3 13.3 0.141‡ 132 p= 0.027 p= 0.023 v1.0 12.04.09 Results Author Outcome LoE Duration N Early Motion Cast Results Cetti, et al. 1994 Suture Granuloma II Not Reported 60 3.3 0 0.155‡ Maffulli, et al 2003 Full weight bearing (wks) II 12 months 53 2.5 (SD 0.4) 5.5 (SD 2.2) p= 0.021 Maffulli, et al 2003 Physiotherapy sessions (visits) II 12 months 53 6.1 (SD 3.1) 13.6 (SD 4.8) p= 0.03 Maffulli, et al 2003 Discharged from Physiotherapy (months) II 12 months 53 2.1 (SD 1.1) 4.6 (SD 2) p<.0001 Maffulli, et al 2003 Pain- None II 12 months 53 88% 89% p= 0.96 ‡ Maffulli, et al 2003 Pain- Mild, Occasional II 12 months 53 8% 7% p=0.97‡ Maffulli, et al 2003 Pain- Moderate II 12 months 53 4% 4% p=0.98 ‡ II 12 months 53 92% 93% p=0.97‡ II 12 months 53 8% 7% p=0.97 Maffulli, et al 2003 Maffulli, et al 2003 Activity Limitation None Activity Limitation Limited Recreational but not Daily Activities Maffulli, et al 2003 Return to Sports II 12 months 38 89% 89% p=0.99 ‡ Maffulli, et al 2003 Return to Sports (months) II 12 months 53 5.1 (SD 2.8) 6 (SD 3) 0.04 II 12 months 53 96% 93% p=0.57‡ II 12 months 53 4% 7% p=0.57‡ Maffulli, et al 2003 Maffulli, et al 2003 Footwear restrictionsNone, mild Footwear restrictionsModerate (unable to tolerate fashionable shoes, with or without insert) 133 v1.0 12.04.09 Results Author Outcome Maffulli, et al 2003 Percent satisfied with results of surgery LoE II Maffulli, et al 2003 Excellent Maffulli, et al 2003 Duration N Early Motion Cast Results 12 months 53 88% 85% p=0.51‡ II 12 months 53 88% 81% p=0.47‡ Return to Work (weeks) II 12 months 53 9.2 (SD 2.5) 13.2 (SD 3) p= 0.05 Maffulli, et al 2003 Return to Work II 12 months 49 100% 100% 1 Maffulli, et al 2003 Changed Jobs II 12 months 49 1 2 p=0.51‡ Maffulli, et al 2003 Hypersensitivity of surgical wounds II 10-12 wks 53 15.38% 18.51% p= 0.76‡ Maffulli, et al 2003 Hypertrophic Scar II 10-12 weeks 53 3.84% 0% p= 0.15‡ ‡= AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks 134 v1.0 12.04.09 Author Cetti, et al. 1994 Cetti, et al. 1994 Outcome LoE Duration N Abnormal Sensibility II Not Reported 60 Keloid Scar II Not Reported 60 Mortensen Deep Infection II Mortensen Failed Repair Costa Kangas, et al 2002 Results Early Motion Cast Results 3.3 16.7 p= 0.066‡ 10 23.3 p= 0.157‡ 6 weeks 3% 0% II 6 weeks 3% 7% Minor Wound Complications II Varying Tie 23% 20% Re-rupture II 5 months 4% 8% Time in weeks taken Time II 48 22 26 to return to measurement work. EuroQoL Costa, et Health II 10 weeks 48 75 (IQR 70-85) 75 (IQR 65-80) al 2006 Score‡‡ EuroQoL Costa, et Health II 6months 48 85 (IQR 80-90) 81 (IQR 75-95) al 2006 Score‡‡ EuroQoL Costa, et Health II 12 months 48 84 (IQR 75-95) 90 (IQR 85-95) al 2006 Score‡‡ E5D Costa, et (Dimension of II 10 weeks 48 0.69 (IQR 0.6-0.9) 0.69 (IQR 0.6-0.7) al 2006 Health Score) E5D Costa, et (Dimension of II 6months 48 0.8 (IQR 0.7-1.0) 0.8 (IQR 0.8-1.0) al 2006 Health Score) E5D Costa, et (Dimension of II 12 months 48 1 (IQR 0.9-1.0) 1(IQR 0.8-1.0) al 2006 Health Score) ‡= AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Costa, et al 2005 135 v1.0 12.04.09 p= 0.154‡ p= 0.52‡ p= 0.79‡ p= 0.545‡ p= 0.593‡ p= 0.854 p= 0.956 p= .138 p= 0.450 p= 0.956 p= 0.146 RECOMMENDATION 13 We are unable to recommend for or against post-operative physiotherapy for patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: A systematic review did not identify any studies that met the inclusion criteria. Supporting Evidence: We searched for any studies addressing post operative physical therapy including supervised and unsupervised physical therapy. The only studies that we identified did not specifically study whether physical therapy was effective. Therefore, it is not possible to draw evidence-based conclusions for this recommendation. SUMMARY OF EVIDENCE Table 134. Post Operative Physiotherapy Regiments Author Majewski LOE Treatment III Percutaneous Repair N 15 88 Calder IV Mini-Open Repair 46 Troop IV Open Repair 13 Saw IV Open Repair 19 Post Treatment Cast followed by walking cast Combination splint and shoe Functional Brace Cast (5) Splint (8) Cast followed by walking boot 136 PT Regimen Both groups received same PT at 8 weeks "Active physiotherapy programme" at 2 weeks All had supervised PT. Authors do not report details of PT regimen. All patients began supervised active ankle dorsiflexion at 1 week. Neutral position of the ankle at 2 weeks. Active non-weight bearing exercises at 6 weeks. Normal walking allowed at 8 weeks. v1.0 12.04.09 Author Moberg N Post Treatment IV Operative Repair 17 Mobile plaster cast II Open Repair 25 Dorsal rigid splint at 6 weeks II Open Repair 25 Plaster splint LOE Treatment Kangas PT Regimen Immediate free ankle joint movement. Free weightbearing and mobilization at 6 weeks. Both groups performed "standard rehabilitation program;" Authors do not specify details of PT program Both groups performed "standard rehabilitation program;" Authors do not specify details of PT program EXCLUDED ARTICLES Table 135. Excluded Articles Author Majewski M, et al Calder JD, et al. Troop RL, et al. Saw Y, et al. Moberg A, et al. Kangas J, et al. Title Postoperative rehabilitation after percutaneous Achilles tendon repair: Early functional therapy versus cast immobilization Early, active rehabilitation following mini-open repair of Achilles tendon rupture: a prospective study Early motion after repair of Achilles tendon ruptures Early mobilization after operative repair of ruptured Achilles tendon Surgically repaired Achilles tendon ruptures with postoperative mobile ankle cast: A 12-month follow-up study with an isokinetic and a dynamic muscle function test Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative regimens 137 Exclusion Reason Does not answer the recommendation Does not answer the recommendation Does not answer the recommendation Does not answer the recommendation Does not answer the recommendation Does not answer the recommendation v1.0 12.04.09 RECOMMENDATION 14 In patients with acute Achilles tendon rupture, irrespective of treatment type, we are unable to recommend a specific time at which patients can return to activities of daily living. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: A systematic review identified 18 studies that reported on return to low impact activities. Our meta-analysis suggested the results of these studies were very different from each other and this is confirmed by examining their individual results (See supporting evidence below). Supporting Evidence: Eighteen studies5, 46, 47, 48, 49, 50, 20,41, 51, 30,21,52,53, 25,48, 19, 40 are included that report data on return to low impact activity. We have tabled the mean length of time to return to activity and the percent of patients able to return after either non-operative or operative treatments (see Table 136 through Table 143). We attempted meta-analysis for the following patient groups and outcomes: mean time for non-operative patients to return to work (I^2 95%), mean time for operative patients to return to work (I^2 >90%), and the percent of operative patients able to return to work at three months (I^2 at 3 months >75%). The results of these studies are so different from each other, as demonstrated by the high heterogeneity, that it is difficult to draw any conclusions about the time to return to recreational or athletic activity. There were too few studies included for each outcome to investigate the reasons for heterogeneity. SUMMARY OF EVIDENCE Table 136. Non-Operative treatment - Percent of patients able to return to work Author LOE Costa, et al. 2006 IV Costa, et al. 2006 Hufner, et al. IV IV Treatment immediate weight bearing mobilization plaster cast immobilization cast and boot N Outcome Duration (months) % of Patients 22 Return to work 12 59% 26 Return to work 12 65% 125 Return to work 0.6 45% 138 v1.0 12.04.09 2006 Table 137. Non-Operative Treatment -Percent of patients able to return to ADL Author LOE Costa, et al. 2006 IV Costa, et al. 2006 IV Treatment immediate weight bearing mobilization plaster cast immobilization N Outcome Duration (months) % of Patients 22 Return to normal walking 12 73% 26 Return to normal walking 12 85% Table 138. Operative Treatment - Percent of patients returning to ADL Author LOE Treatment N Outcome Duration (months) % Scarfi, et al. 2002 IV percutaneous repair 20 Return to ADL 2 100% Tang, et al. 2007 IV arthroscopically assisted percutaneous 20 Resume walking 3 100% Costa, et al. 2006 IV open end-to-end (immediate weight bearing mobilisation) 23 Return to normal walking 12 96% Costa, et al. 2006 IV open end-to-end (plaster cast immobilisation) 25 Return to normal walking 12 100% Costa, et al. 2006 IV open end-to-end (immediate weight bearing mobilisation) 23 Return to stair climbing 12 96% Costa, et al. 2006 IV open end-to-end (plaster cast immobilisation) 25 Return to stair climbing (months) 12 96% 139 v1.0 12.04.09 Table 139. Operative Treatment - Percent of patients able to return to work Author LOE Treatment N Outcome Duration (months) % Kiviluoto, et al. 1985 IV open repair 70 Return to work 1-3 70% Hogsaa, et al. 1990 IV open repair 68 Return to work same employment (weeks) 1.5-3 35% Moller, et al. 2001 IV end-to-end suture w/o augmentation 32 Return to light, mobile work 1 100% Moller, et al. 2001 IV end-to-end suture w/o augmentation 13 Return to sedentary work 1 100% Hogsaa, et al. 1990 IV open repair 68 Return to work same employment (weeks) <1 29% IV open repair 103 Return to work 1.7 65% IV limited open 27 Return to work 2 100% IV open repair 68 Return to work same employment (weeks) >3 15% IV open repair 103 Return to work 3 82% IV end-to-end suture w/o augmentation 14 Return to heavy work 3.5 100% IV fibrin sealant 32 Return to daily work 6 97% IV open repair 68 Return to work same employment (weeks) <6 18% IV open repair 103 Return to work 6 97% IV minimally-invasive 150 Return to work same work 12 98% Suchak, et al. 2008 Jung, et al. 2008 Hogsaa, et al. 1990 Suchak, et al. 2011 Moller, et al. 2001 Kuskucu, et al. 2005 Hogsaa, et al. 1990 Suchak, et al. 2008 Lansdaal, et al. 2007 140 v1.0 12.04.09 Author LOE Treatment N Outcome Duration (months) % Costa, et al. 2006 IV open end-to-end (immediate weight bearing mobilisation) 23 Return to work 12 87% Costa, et al. 2006 IV open end-to-end (plaster cast immobilisation) 25 Return to work 12 100% IV open repair (non-weight bearing) 26 Return to work same job 12 92% IV open repair (non-weight bearing) 26 Return to work 12 100% IV open repair (weight bearing) 23 Return to work same job 12 96% IV open repair (weight bearing) 23 Return to work 12 100% Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 141 v1.0 12.04.09 Table 140. Non-Operative Treatment - Mean time until return to work Author LOE Metz, et al. IV 2008 Costa, et al. IV 2006 Costa, et al. IV 2006 Moller, et al. IV 2001 Wallace, et al. IV 2004 Cetti, et al. IV 1993 Costa, et al. IV 2006 Moller, et al. IV 2001 Moller, et al. IV 2001 Costa, et al. IV 2006 ‡ AAOS Calculation Treatment N Outcome Duration (weeks) functional brace 33 Return to work 15.4 (SD 16.42) 22 Return to work 1 (95% CI 1-13) ‡ 22 Return to normal walking 18 (95% CI 12-22) ‡ 53 Return to work 10.48 (SD 8.07) cast 122 Return to work 2.36 (SD 1.19) below-knee plaster cast 55 Return to work 8 (SD 3.6) 26 Return to work 10 (95% CI 2-22) ‡ immediate weight bearing mobilisation immediate weight bearing mobilisation Below the knee plaster cast plaster cast immobilisation Below the knee plaster cast Below the knee plaster cast plaster cast immobilisation 22 22 26 Return to light, mobile work Return to sedentary work Return to normal walking 9.6 (SD 9.4) 4.7 (SD7.8) 18 (95% CI 18-22) ‡ Table 141. Non-Operative Treatment - Mean time until return to walking Author Costa, et al. 2006 Costa, et al. 2006 LOE IV IV Treatment immediate weight bearing mobilisation plaster cast immobilisation 142 N 22 26 Outcome Return to normal walking Return to normal walking Duration (weeks) 18 (95% CI 12-22) ‡ 18 (95% CI 18-22) ‡ v1.0 12.04.09 Table 142. Operative Treatment - Mean time to return to ADL Author LOE Costa, et al. 2006 IV Costa, et al. 2006 Maffulli, et al. 2003 Maffulli, et al. 2003 Costa, et al. 2006 IV IV IV IV Costa, et al. IV 2006 Calder, et IV al. 2006 ‡ AAOS Calculation Treatment open end-to-end (immediate weight bearing mobilisation) open end-to-end (plaster cast immobilisation) open repair (non-weight bearing) open repair (weight bearing) open end-to-end (immediate weight bearing mobilisation) open end-to-end (plaster cast immobilisation) percutaneous repair 143 N Outcome Duration (Weeks) 23 Return to normal walking 12.5 (95% CI 1018) ‡ 25 Return to normal walking 27 Walk w/o crutches 26 Walk w/o crutches 18 (95% CI 18-22) ‡ 5.5 (SD 2.2; range 4.6-8.1) 2.5 (SD 0.4; range 1.2-3.1) 23 Return to stair climbing 13 (95% CI 10-18) ‡ 25 Return to stair climbing 22 (95% CI 18-22) ‡ 25 Return to driving 4.14 (range .7-9) v1.0 12.04.09 Table 143. Operative Treatment - Mean time until return to work Author Moller, et al. 2001 Coutts, et al. 2002 Moller, et al. 2001 Moller, et al. 2001 Moller, et al. 2001 Cetti, et al. 1993 Metz, et al. 2008 Lansdaal, et al. 2007 LOE IV IV IV IV IV Treatment end-to-end suture w/o augmentation open repair end-to-end suture w/o augmentation end-to-end suture w/o augmentation end-to-end suture w/o augmentation N Outcome Return to heavy work Return to work manual Return to light, mobile work Return to sedentary work Duration (Weeks) 59 Return to work 7.8(SD 68.4) 14 15 32 13 14.6 (SD 7.5) 11.1 (range 8-24) 5.1 (SD 5.4) 4.4(SD 5.2) IV end-to-end suture 56 Return to work 6.2 (SD 2.15) IV minimally-invasive 40 Return to work 8.4 (SD 11.71) IV minimally-invasive 15 0 Return to work 4 (range .14-52.57) ‡ 46 Return to work 3.12 (range .57-11) 23 Return to work 8 (95% CI 2-13) ‡ 25 Return to work 4 (95% CI 1-13) ‡ percutaneous repair 25 Return to work 2.7 (range .85-11) percutaneous w/ shoe 14 Return to work 5.2 (range .7-18.85) 22 Return to work (months) 1.07 62 Return to work 11.7 (range 10-13) Calder, et al. 2005 IV Costa, et al. 2006 IV Costa, et al. 2006 IV Calder, et IV al. 2006 Majewski, IV et al. 2008 Wagnon, et IV al. 2005 Doral, et al. IV 2009 ‡ AAOS Calculation mini-open repair w/ early active rehabilitation open end-to-end (immediate weight bearing mobilisation) open end-to-end (plaster cast immobilisation) percutaneous repair (Webb-Bannister) endoscopy assisted percutaneous 144 v1.0 12.04.09 EXCLUDED ARTICLES Table 144. Excluded Articles Author Costa ML;Shepstone L;Darrah C;Marshall T;Donell ST; Goren D;Ayalon M;Nyska M; van der Linden-van der Zwaag HM;Nelissen RG;Sintenie JB; Kakiuchi M; Hufner TM;Brandes DB;Thermann H;Richter M;Knobloch K;Krettek C; Roberts C;Rosenblum S;Uhl R;Fetto J; Mortensen HM;Skov O;Jensen PE; Maes R;Copin G;Averous C; Cretnik A;Kosanovic M;Smrkolj V; Chiodo CP;Wilson MG; Fernandez-Fairen M;Gimeno C; Wagnon R;Akayi M; Martinelli B; Park HG;Moon DH;Yoon JM; Edna TH; Title Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study Isokinetic strength and endurance after percutaneous and open surgical repair of Achilles tendon ruptures Results of surgical versus nonsurgical treatment of Achilles tendon rupture A combined open and percutaneous technique for repair of tendo Achilles. Comparison with open repair Long-term results after functional nonoperative treatment of Achilles tendon rupture Reason for Exclusion Less than 80% follow up No patient oriented outcome Not 80% follow Not 80% time follow up Not best available evidence Team physician #6. Surgical treatment of Achilles tendon rupture Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. A prospective, randomized clinical and radiographic study Is percutaneous repair of the Achilles tendon a safe technique? A study of 124 cases Percutaneous versus open repair of the ruptured Achilles tendon: a comparative study Current concepts review: acute ruptures of the Achilles tendon Augmented repair of Achilles tendon ruptures The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures: a functional and MRI assessment Percutaneous repair of the Achilles tendon in athletes Limited open repair of ruptured Achilles tendons with Bunnel-type sutures Not best available evidence Non-operative treatment of Achilles tendon ruptures Not best available evidence 145 Not best available evidence Not best available evidence Not best available evidence Not best available evidence Not best available evidence Not best available evidence Not best available evidence Not best available evidence v1.0 12.04.09 Author Jessing P;Hansen E; Keller J;Rasmussen TB; Majewski M;Rohrbach M;Czaja S;Ochsner P; Jennings AG;Sefton GK;Newman RJ; Suchak AA;Bostick GP;Beaupre LA;Durand DC;Jomha NM; Pendleton H;Resch S;Stenstrom A;Astrom I; Weber M;Niemann M;Lanz R;Muller T; Title Surgical treatment of 102 tendo achillis ruptures-- suture or tenontoplasty? Closed treatment of Achilles tendon rupture Avoiding sural nerve injuries during percutaneous Achilles tendon repair Repair of acute rupture of the Achilles tendon: a new technique using polyester tape without external splintage The influence of early weight bearing compared with non-weight bearing after surgical repair of the Achilles tendon Residual functional problems after non-operative treatment of Achilles tendon rupture Nonoperative treatment of acute rupture of the Achilles tendon: results of a new protocol and comparison with operative treatment 146 Reason for Exclusion Not best available evidence Not best available evidence Not best available evidence Not best available evidence Does not report relevant outcomes Retrospective Retrospective v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time STUDY QUALITY Table 145. Patient return to activities of daily living Calder, et al. 2005 Return to previous sporting activities 46 IV ● ● ● ● x Calder, et al. 2006 Return to previous sporting activities 25 IV ● ● ● ● x Cetti, et al. 1993 Return to sports - same level 47 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - same level 52 IV ● ● ● ● ● Chillemi, et al. 2002 Return to sports - frequent‡‡ (months) 14 IV ● ● ● ● ● Costa, et al. 2006 Costa, et al. 2006 Return to sports Return to sports 23 25 IV ● ● ● ● ● ● ● ● 26 IV x x x ● ● ● ● 22 IV x ● ● ● ● 23 IV ● ● ● ● 22 IV x x ● ● ● ● 20 IV x ● ● ● ● ●= yes ○= no x= not reported Costa, et al. 2006 Costa, et al. 2006 Costa, et al. 2006 Coutts, et al. 2002 Coutts, et al. 2002 Return to stair climbing (weeks) Return to stair climbing (weeks) Return to sports (weeks) Return to pre-injury level of sporting participation Return to sports IV Doral, et al. 2009 Return to previous sporting activities 62 IV ● ● ● ● ● Doral, et al. 2009 Rehabilitation training 62 IV ● ● ● ● ● Fortis, et al. 2008 Return to previous activity levels 20 IV x ● ● ● ● Garabito, et al. 2004 Return to sports - pre-injury level 54 IV ● ● ● ● ● Giannini, et al. 1994 Return to pre-injury level of activity 15 IV ● ● ● ● ● Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ● Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● x Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ● 147 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Jung, et al. 2008 Resume light exercise 27 IV x ● ● ● ● Jung, et al. 2008 Return to previous sporting activities 27 IV x ● ● ● ● Kuskucu, et al. 2005 Return to amateur sports activity 32 IV x ● ● ● ● Lansdaal, et al. 2007 Return to sports - same level 152 IV x ● ● ● ● Lansdaal, et al. 2007 Return to sports 152 IV x ● ● ● ● Activity limitations - none 27 IV ● ● ● ● ● Activity limitations - none 26 IV ● ● ● ● ● Return to sports 19 IV ● ● ● ● ● Return to sports 19 IV ● ● ● ● ● Return to sports 19 IV ● ● ● ● ● Return to sports 19 IV ● ● ● ● ● Return to sports 24 IV ● ● ● ● ● Return to sports Return to sports 33 36 IV ● ● ● ● ● IV ● ● ● ● ● Moller, et al. 2001 Return to sports - same level 47 IV ● ● ● ● ● Scarfi, et al. 2002 Return to sports activities 20 IV x ● ● ● ● Solveborn, et al. 1994 Solveborn, et al. 1994 Taglialavoro, et al. 2004 Return to previous sports activity w/o any difficulty 16 IV ● ● ● ● ● Return to sports 16 IV ● ● ● ● ● Return to sports - complete 24 IV ● ● ● ● ● Return to sports - complete 22 IV ● ● ● ● ● Return to sports level Resume jogging/running Resume jogging/running 6 13 IV x ● ● ● ● IV IV ● ● ● ● ● ● ● ● ● ● ●= yes ○= no x= not reported Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2003 Maffulli, et al. 2009 Metz, et al. 2008 Metz, et al. 2008 Taglialavoro, et al. 2004 Tang, et al. 2007 Troop, et al. 1995 Troop, et al. 1995 148 13 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Uchiyama, et al. 2007 Resume jogging (weeks) 84 IV x ● ● ● ● Uchiyama, et al. 2007 Return to sports for high-level athletes - original game level 21 IV x ● ● ● ● Wallace, et al. 2004 Return to sports (weeks) 101 IV ● ● ● ● x ●= yes ○= no x= not reported 149 v1.0 12.04.09 RECOMMENDATION 15 In patients who participate in sports it is an option to return them to sports within 3-6 months after operative treatment for acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale: A systematic review identified 23 level IV studies providing data on return to sports after operative treatment. Two studies54, 51 reported return to jogging at three months. One study 47 reported return to sport at four months. Five studies55, 32,54, 51,56 reported that 83%-100% of patient returned to sports at six months. Ten studies19,57, 58, 53, 56, 54 , 40, 5, 21, 20 reported that 32-100% of patients returned to sports at 12 months or more. Supporting Evidence: Twenty-three21,5,20, 19, 50,39, 59,54,51,47,32,57, 58,38,25, 60,53,28,30,34, 55, 40studies are included that report data on return to athletic activity. We have tabled the percent of patients able to return to recreational and sports activities after operative treatments and the mean length of time to return to athletic activity (see Table 146 through Table 148 ). We attempted meta-analysis for the following patient groups and outcomes: percent operative patients able to return to activity at ≥ 12 months (I2>80%) (see Table 146 ) percent of operative patients able to return to sports at 6 and at 12 months (I2>90%) (see Table 147), and mean time for operative patients to return to sports (I2>95%) (see Table 148). The results of these studies are so different from each other, as demonstrated by the high heterogeneity, that it is difficult to draw any conclusions about the time to return to recreational or athletic activity. There were too few studies included for each outcome to investigate the reasons for heterogeneity. The remainder of outcomes and patient groups do not include enough studies to attempt meta-analysis. 150 v1.0 12.04.09 SUMMARY OF EVIDENCE Table 146. Operative Treatment - Return to Recreational Activity Author Hogsaa, et al. 1990 LOE Treatment N IV open repair 63 Hogsaa, et al. 1990 IV open repair 63 Hogsaa, et al. 1990 IV open repair Maffulli, et al. 2003 IV Maffulli, et al. 2003 Duration (months) % 6-12 30% Resumption of recreational activities 3-6 33% 63 Resumption of recreational activities <3 10% open repair (nonweight bearing) 27 Activity limitations - none 12 93% IV open repair (weight bearing) 26 Activity limitations - none 12 92% Hogsaa, et al. 1990 IV open repair 63 Resumption of recreational activities > 12 51% Giannini, et al. 1994 IV 15 Return to pre-injury level of activity 18 100% Fortis, et al. 2008 IV 20 Return to previous activity levels 30 100% adjunctive augmentation (synthetic graft) endoscopically assisted percutaneous Outcome Resumption of recreational activities Table 147. Operative Treatment - Return to sports Author Troop, et al. 1995 LOE IV Treatment end-to-end w/ early motion N Outcome Duration (months) % 13 Resume jogging/running 3 92% Jung, et al. 2008 IV limited open 27 Resume light exercise 3 100% Troop, et al. 1995 IV end-to-end w/ early motion 13 Resume jogging/running 3 92% Scarfi, et al. 2002 IV percutaneous repair 20 Return to sports activities 4 100% Kuskucu, et al. 2005 IV fibrin sealant 32 Return to amateur sports activity 6 97% Aktas, et al. 2007 IV 16 Return to sports - pre-injury level of activity 6 85% Tang, et al. 2007 IV 6 Return to sports level 6 83% Jung, et al. 2008 IV 27 Return to previous sporting activities 6 100% adjunctive augmentation (autograft) arthroscopically assisted percutaneous limited open 151 v1.0 12.04.09 Author LOE Calder, et al. 2005 IV Aktas, et al. 2008 IV Calder, et al. 2006 Cetti, et al. 1993 Duration (months) % Return to previous sporting activities 6 100% 14 Return to sports - pre-injury level of activity 6 89% percutaneous repair 25 Return to previous sporting activities 6 100% end-to-end suture 52 Return to sports - same level 12 62% 16 Return to previous sports activity w/o any difficulty 12 81% 16 Return to sports 12 100% 47 Return to sports - same level 12 54% 36 Return to sports 12 67% 152 Return to sports - same level 12 64% 23 Return to sports 12 83% 25 Return to sports 12 68% 19 Return to sports 12 89% 19 Return to sports 12 89% 24 Return to sports - complete 42 38% 22 Return to sports - complete 42 32% 62 Return to previous sporting activities 46 95% 54 Return to sports - pre-injury level 96 43% N Outcome 46 open repair IV IV Solveborn, et al. 1994 IV Solveborn, et al. 1994 IV Moller, et al. 2001 IV Metz, et al. 2008 IV Lansdaal, et al. 2007 IV Costa, et al. 2006 IV Costa, et al. 2006 IV Maffulli, et al. 2003 IV Maffulli, et al. 2003 IV Taglialavoro, et al. 2004 IV Taglialavoro, et al. 2004 IV Doral, et al. 2009 IV Garabito, et al. 2004 IV Treatment mini-open repair w/ early active rehabilitation end-to-end suture w/ below-knee transport splint cast end-to-end suture w/ below-knee transport splint cast end-to-end suture w/o augmentation minimallyinvasive minimallyinvasive open end-to-end (immediate weight bearing mobilisation) open end-to-end (plaster cast immobilisation) open repair (nonweight bearing) open repair (weight bearing) adjunctive augmentation (autograft) open repair endoscopy assisted percutaneous adjunctive augmentation (autograft) 152 v1.0 12.04.09 Table 148. Operative Treatment - Mean time to return to athletic activity Author Doral, et al. 2009 Troop, et al. 1995 Lansdaal, et al. 2007 LOE IV IV Treatment N endoscopy assisted percutaneous end-to-end w/ early motion 62 13 Duration (months) Outcome Rehabilitation training Resume jogging/running 11.7 (SD 0.75) 3 (SD 0.75) IV minimally-invasive 152 Return to sports 7.1 (SD 3.8) Costa, et al. 2006 IV open end-to-end (immediate weight bearing mobilisation) 23 Return to sports (weeks) 11.14 (95% CI 5-17) ‡ Uchiyama, et al. 2007 IV open repair 84 Coutts, et al. 2002 IV open repair 22 Coutts, et al. 2002 IV open repair 20 Return to sports 4.5 (SD 2.14) Uchiyama, et al. 2007 IV open repair 21 Return to sports for high-level athletes original game level 5 (SD .35) 19 Return to sports 6 (SD 3) 19 Return to sports 5.1 (SD 2.8) Maffulli, et al. 2003 Maffulli, et al. 2003 Gorschewsky, et al. 2004 Maffulli, et al. 2009 Chillemi, et al. 2002 IV IV open repair (nonweight bearing) open repair (weight bearing) Resume jogging (weeks) Return to pre-injury level of sporting participation 3.5(SD .9) 40.8 (SD 25.2) IV percutaneous repair 66 Return to original sport 5.46 (SD 1.5) IV percutaneous repair 24 Return to sports 88 (SD 14.5) IV percutaneous repair 14 Return to sports frequent‡ (months) 8 (SD 1.5) EXCLUDED ARTICLES Table 149. Excluded Articles Author Suchak AA;Bostick GP;Beaupre LA;Durand DC;Jomha NM; Majewski M;Rohrbach M;Czaja S;Ochsner P; Title Reason for Exclusion The influence of early weight bearing compared No relevant with non-weight bearing after surgical repair of the outcomes Achilles tendon Avoiding sural nerve injuries during percutaneous Not best available Achilles tendon repair evidence 153 v1.0 12.04.09 Author Title Reason for Exclusion Time of return to sports not reported The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures: a functional and MRI assessment Isokinetic strength and endurance after Goren D;Ayalon M;Nyska No patientpercutaneous and open surgical repair of Achilles M; oriented outcome tendon ruptures Current concepts review: acute ruptures of the Not best available Chiodo CP;Wilson MG; Achilles tendon evidence Cretnik A;Kosanovic Percutaneous versus open repair of the ruptured Not best available M;Smrkolj V; Achilles tendon: a comparative study evidence Repair of acute rupture of the Achilles tendon: a Jennings AG;Sefton Not best available new technique using polyester tape without external GK;Newman RJ; evidence splintage van der Linden-van der Results of surgical versus non-surgical treatment of Less than 80% Zwaag HM;Nelissen Achilles tendon rupture follow up RG;Sintenie JB; Costa ML;Shepstone Immediate full-weight bearing mobilisation for Less than 80% L;Darrah C;Marshall repaired Achilles tendon ruptures: a pilot study follow up T;Donell ST; Early motion of the ankle after operative treatment Mortensen HM;Skov Not best available of a rupture of the Achilles tendon. A prospective, O;Jensen PE; evidence randomized clinical and radiographic study A combined open and percutaneous technique for Less than 80% Kakiuchi M; repair of tendo Achillis. Comparison with open follow up repair Roberts C;Rosenblum S;Uhl Team physician #6. Surgical treatment of Achilles Not best available R;Fetto J; tendon rupture evidence Not best available Keller J;Rasmussen TB; Closed treatment of Achilles tendon rupture evidence Percutaneous repair of the Achilles tendon in Not best available Martinelli B; athletes evidence Fernandez-Fairen Not best available Augmented repair of Achilles tendon ruptures M;Gimeno C; evidence Park HG;Moon DH;Yoon Limited open repair of ruptured Achilles tendons Not best available JM; with Bunnel-type sutures evidence Wagnon R;Akayi M; 154 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time STUDY QUALITY Table 150. Return to sports Aktas, et al. 2007 Return to sports - pre-injury level of activity 16 IV ● ● ● ● ● Aktas, et al. 2008 Return to sports - pre-injury level of activity 14 IV ● ● ● ● ● Calder, et al. 2005 Return to previous sporting activities 46 IV ● ● ● ● x Calder, et al. 2006 Return to previous sporting activities 25 IV ● ● ● ● x Cetti, et al. 1993 Return to sports - same level 47 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - same level 52 IV ● ● ● ● ● Chillemi, et al. 2002 Return to sports - frequent‡ (months) 14 IV ● ● ● ● ● Costa, et al. 2006 Return to sports 23 IV x ● ● ● ● Costa, et al. 2006 Return to sports 25 IV x ● ● ● ● Costa, et al. 2006 Return to stair climbing (weeks) 26 IV x ● ● ● ● Costa, et al. 2006 Return to stair climbing (weeks) 22 IV x ● ● ● ● Costa, et al. 2006 Return to sports (weeks) 23 IV x ● ● ● ● Coutts, et al. 2002 Return to pre-injury level of sporting participation 22 IV x ● ● ● ● Coutts, et al. 2002 Return to sports 20 IV x ● ● ● ● Doral, et al. 2009 Return to previous sporting activities 62 IV ● ● ● ● ● Doral, et al. 2009 Rehabilitation training 62 IV ● ● ● ● ● ●= yes ○= no x= not reported 155 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Fortis, et al. 2008 Return to previous activity levels 20 IV x ● ● ● ● Garabito, et al. 2004 Return to sports - pre-injury level 54 IV ● ● ● ● ● Giannini, et al. 1994 Return to pre-injury level of activity 15 IV ● ● ● ● ● Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ● Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ● Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ● Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ● Jung, et al. 2008 Resume light exercise 27 IV x ● ● ● ● Jung, et al. 2008 Return to previous sporting activities 27 IV x ● ● ● ● Kuskucu, et al. 2005 Return to amateur sports activity 32 IV ● ● ● ● ● Lansdaal, et al. 2007 Return to sports - same level 152 IV x ● ● ● ● Lansdaal, et al. 2007 Return to sports 152 IV x ● ● ● ● Re-rupture 33 IV ● ● ● ● ● Absence from work 33 IV ● ● ● ● ● Return to sport 33 IV ● ● ● ● ● Pain - VAS 33 IV ● ● ● ● ● Pain - VAS 33 IV ● ● ● ● ● ●= yes ○= no x= not reported Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 156 v1.0 12.04.09 Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Pain - VAS 33 IV ● ● ● ● ● Satisfaction - VAS 33 IV ● ● ● ● ● Satisfaction - VAS 33 IV ● ● ● ● ● Satisfaction - VAS 33 IV ● ● ● ● ● Return to sedentary work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to heavy work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to sports - same level 59 IV ● ● ● ● ● Moller, et al. 2001 Return to sports - stopped 59 IV ● ● ● ● ● Moller, et al. 2001 Return to sedentary work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ● Scarfi, et al. 2002 Return to sports activities 20 IV x ● ● ● ● Solveborn, et al. 1994 Return to previous sports activity w/o any difficulty 16 IV ● ● ● ● ● Return to sports 16 IV ● ● ● ● ● Return to sports - complete 24 IV ● ● ● ● ● Return to sports - complete 22 IV ● ● ● ● ● ●= yes ○= no x= not reported Author Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Solveborn, et al. 1994 Taglialavoro, et al. 2004 Taglialavoro, et al. 2004 157 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Uchiyama, et al. 2007 Return to sports for high-level athletes - original game level 21 IV ● ● ● ● ● Cetti, et al. 1993 Return to work (weeks) 56 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - diminished level 56 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - same level 56 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - stopped 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ● Chillemi, et al. 2002 Able to walk without limitation Return to sports activity (frequent participant 2-3 times per week) 38 IV ● ● ● ● ● 14 IV ● ● ● ● ● ●= yes ○= no x= not reported Chillemi, et al. 2002 158 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Coutts, et al 2002 Return to pre-injury sporting level 22 IV x ● ● ● ● Maffulli, et al. 2003 Activity limitations - none 27 IV ● ● ● ● ● Maffulli, et al. 2003 Activity limitations - none 26 IV ● ● ● ● ● Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ● Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ● Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ● Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ● Maffulli, et al. 2009 Return to sports 24 IV ● ● ● ● ● Troop, et al. 1995 Resume jogging/running 13 IV ● ● ● ● ● Troop, et al. 1995 Resume jogging/running 13 IV ● ● ● ● ● Tang, et al. 2007 Return to sports level 6 IV x ● ● ● ● ●= yes ○= no x= not reported 159 v1.0 12.04.09 RECOMMENDATION 16 In patients with acute Achilles tendon rupture treated non-operatively, we are unable to recommend a specific time at which patients can return to athletic activity. AAOS Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: A systematic review identified 5 level IV studies21,5,20, 19,25 providing data on return to sports after non-operative treatment. These studies did not provide adequate evidence to make a recommendation for the specific time patients can return to athletic activity following non-operative treatment for Achilles tendon rupture. Supporting Evidence: Five Level IV studies21,5,20, 19,25 that provided data on return to sports after non-operative treatment were identified. We have tabled the percent of patients and the mean length of time to return to athletic activity reported by the authors of these studies (see Table 151 and Table 152). The lack of studies, variation in treatments and variation in reported outcomes makes it difficult to draw any conclusions about the time to return to athletic activity following non-operative treatment. SUMMARY OF EVIDENCE Table 151. Non-Operative Treatment - Percent of patients returning to athletic activity Author Metz, et al. 2008 Costa, et al. 2006 Costa, et al. 2006 Moller, et al. 2001 Cetti, et al. 1993 LOE Treatment N Outcome Duration (months) % IV functional brace 33 Return to sports 12 82% 12 56% 12 52% 12 54% 12 34 % IV IV IV IV immediate weight bearing mobilisation plaster cast immobilisation below the knee plaster cast below-knee plaster cast 18 21 38 47 160 Return to sports (months) Return to sports (months) Return to sports - same level (months) Return to sports-same level v1.0 12.04.09 161 v1.0 12.04.09 Table 152. Non-Operative Treatment - Mean time until patients return to athletic activity Author Wallace, et al. 2004 LOE IV Costa, et al. 2006 IV Costa, et al. 2006 IV Treatment Duration (weeks) N Outcome cast plaster cast immobilisation immediate weight bearing mobilisation 162 101 Return to sports (weeks) 10 (SD 4.9) 26 Return to stair climbing (weeks) 18 (95% CI 14-22) ‡ 22 Return to stair climbing (weeks) 17 (95% CI 11-18) ‡ v1.0 12.04.09 EXCLUDED ARTICLES Table 153. Excluded studies Author Reason for Exclusion Current concepts review: acute ruptures of the Not best available Achilles tendon evidence Title Chiodo CP;Wilson MG; van der Linden-van der Zwaag HM;Nelissen RG;Sintenie JB; Costa ML;Shepstone L;Darrah C;Marshall T;Donell ST; Weber M;Niemann M;Lanz R;Muller T; Pendleton H;Resch S;Stenstrom A;Astrom I; Results of surgical versus non-surgical treatment of Achilles tendon rupture Less than 80% follow up Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study Less than 80% follow up Nonoperative treatment of acute rupture of the Achilles tendon: results of a new protocol and comparison with operative treatment Residual functional problems after non-operative treatment of Achilles tendon rupture Retrospective Retrospective Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time STUDY QUALITY Table 154. Study Quality Cetti, et al. 1993 Return to sports - same level 47 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - same level 52 IV ● ● ● ● ● Costa, et al. 2006 Return to sports 23 IV x ● ● ● ● Costa, et al. 2006 Return to sports 25 IV x ● ● ● ● Costa, et al. 2006 Return to stair climbing (weeks) 26 IV x ● ● ● ● Costa, et al. 2006 Return to stair climbing (weeks) 22 IV x ● ● ● ● Re-rupture 33 IV ● ● ● ● ● ●= yes ○= no x= not reported Metz, et al. 2008 163 v1.0 12.04.09 Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Absence from work 33 IV ● ● ● ● ● Return to sport 33 IV ● ● ● ● ● Pain - VAS 33 IV ● ● ● ● ● Pain - VAS 33 IV ● ● ● ● ● Pain - VAS 33 IV ● ● ● ● ● Satisfaction - VAS 33 IV ● ● ● ● ● Satisfaction - VAS 33 IV ● ● ● ● ● Satisfaction - VAS 33 IV ● ● ● ● ● Return to sedentary work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to heavy work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to sports - same level 59 IV ● ● ● ● ● Moller, et al. 2001 Return to sports - stopped 59 IV ● ● ● ● ● Moller, et al. 2001 Return to sedentary work (days) 59 IV ● ● ● ● ● Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ● Wallace, et al. 2004 Return to sports (weeks) 101 IV x ● ● ● ● ●= yes ○= no x= not reported Author Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 Metz, et al. 2008 164 v1.0 12.04.09 Author Outcome Measure N LoE Consecutive Follow up 80 Same Outcomes Same Treatment Equal Follow up Time Cetti, et al. 1993 Return to sports - same level 56 IV ● ● ● ● ● Cetti, et al. 1993 Return to sports - stopped 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ● Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ● ●= yes ○= no x= not reported 165 v1.0 12.04.09 FUTURE RESEARCH While the current guideline is instructive in many ways, it also demonstrates a substantial need for future research. Wherever the strength of a specific Recommendation is limited or inconclusive, there exists a need for well-designed studies and high-level evidence. As such, the most obvious need is for further, high-level investigations into the fundamental question of whether or not surgical management is superior to non-operative management of acute Achilles ruptures. There are hundreds of studies that are centered on this question, but too few are high-level randomized control trials. Beyond this, there are several other areas of needed research. Does the clinician routinely need MRI or an ultrasound for the diagnosis of an Achilles rupture? Probably not. However, there are no high-level studies to help answer this question. For nonoperative treatment, low-level evidence supports the use of immediate functional bracing, but again more randomized trials are necessary. Post-operatively, is DVT prophylaxis necessary? Does the patient really need physical therapy? These are very important questions that so far remain unanswered. 166 v1.0 12.04.09 IV. APPENDIXES 167 v1.0 12.04.09 APPENDIX I Guidelines and Technology Oversight Chair: William C. Watters, III, MD 6624 Fannin #2600 Houston, TX 77030 WORK GROUP Christopher P Chiodo MD, Chair Brigham Orthopedic Associates 75 Francis Street Boston MA 02115 Guidelines and Technology Oversight ViceChair: Michael J. Goldberg, MD Department of Orthopaedics Seattle Children’s Hospital 4800 Sand Point Way NE Seattle, WA 98105 Mark Glazebrook MD, Vice-Chair Queen Elizabeth Health Sciences Center Halifax Infirmary Suite 4867 1796 Summer Street Halifax NS B3H 3A7 Canada Eric Michael Bluman MD PhD Madigan Army Medical Center ATTN: MCHJ-SOP (Ortho Clinic) 9040 A Reid Street Tacoma WA 98431-1100 Evidence Based Practice Committee Chair: Michael Keith, MD 2500 Metro Health Drive Cleveland, OH 44109-1900 Bruce E Cohen MD 1783 Sterling Road Charlotte NC 28209 AAOS Staff: Robert H. Haralson III, MD, MBA AAOS Medical Director 6300 N River Road Rosemont, IL 60018 John E Femino MD Department of Orthopedics University of Iowa Hospital and Clinics JPP 01022 200 Hawkins Drive Iowa City IA 52242 Charles M. Turkelson, PhD Director of Research and Scientific Affairs Janet L. Wies MPH AAOS Clinical Practice Guideline Mgr Eric Giza MD UC Davis Dept of Orthopaedics Ambulatory Care Services Bldg 4860 Y St #3800 Sacramento, CA 95817 AAOS Research Analysts Laura Raymond MA - Lead Analyst Sara Anderson MPH Kevin Boyer BS Patrick Sluka MPH 168 v1.0 12.04.09 APPENDIX II TIME FROM RUPTURE TO TREATMENT Table 155. Time from injury to treatment Author Time from Injury to treatment Maffulli, et al. 1998 0-3 days, 45 patients 4-7 days, 14 patients 8-14 days, 7 patients 14-28 days, 10 patients Moller, et al 2001 Attended hospital within 3 days Non-op group treated immediately Surgery performed within 2 days in 95% of cases Metz, et al. 2008 Within 3 days of rupture Cetti, et al 1993 Mean 0.6 days (range 0-7 days) Twaddle, et al 2007 Presented within 10 days of injury Operated within 48 hours Ingvar, et al. 2005 1 day after injury, 25 patients 2-7 days after injury, 10 patients 8-31 days after injury, 11 patients Saleh, et al. 1992 Presented within 48 hours of injury Neumayer, et al. 2009 Less than ten days Wallace, et al. 2004 Mean 22 hours (range 1 hour, 17.5 days) Bhattacharyya, et al 2008 7 days Uchiyama, et al. 2007 Acute not defined 169 v1.0 12.04.09 Author Time from Injury to treatment Lim, et al. 2001 Presented less than 7 days Coutts, et al. 2002 Time to presentation: 24 hours, 13 patients 1-14 days, 7 patients 4-18 weeks, 5 patients Operated on within an average of 3 days (range 24 hours -10 days) from presentation Aktas, et al 2007 1.5 days (range 2-56 hours) Aktas, et al 2009 1.5 days (range 2-56 hours) Ng et al. 2006 within 7 days (85% treated within one day) Chellemi, et al. 2002 Within 4 days Gigante, et al. 2007 Acute not defined Kakiuchi, et al 1995 Range 1-9 days Giannini, et al 1994 6 days Taglialavoro, et al 2004 Not Reported Suchak, et al. 2008 Within 2 weeks of injury Maffulli, et al. 2003 (a) 0-7 days 170 v1.0 12.04.09 Author Time from Injury to treatment Maffulli, et al. 2003 (b) 0-7 days Costa, et al. 2005 0-7 days Mortensen, et al. 1999 0-48 hours to presentation Cetti, et al 1993 7-112 hours Kangas, et al 2002 0-7 days Scarfi, et al 2002 2 days (range 1-5 days) Hogsaa, et al 1990 Less than 3 days, 96% of patients More than 3 days, 4% of patients Doral, et al 2009 0-10 days Troop, et al 1995 0-2 weeks Kuskucu, et al 2005 Average 4 days (range, 3-8 days) Solveborn, et al. 1994 Average 1.8 days (range, 0-5 days) Lansdaal, et al. 2007 0-2 weeks 171 v1.0 12.04.09 Author Time from Injury to treatment Garbito, et al. 2004 Within 24 hours of injury Gorschewsky, et al 2004 Average within 24 hours Hufner, et al. 2006 Within one week Tang, et al 2007 6 hours- 18 days Jung, et al 2008 Mean 5.4 days ( range 1-23 days) 87% of patients were operated in less than 2 weeks Wagnon, et al 2005 Less than 2 weeks to presentation Aktas, et al 2009 1.5 days (range 2-56 hours) Margetic, et al 2007 Not Reported McComis, et al. 1997 Not Reported Fortis, et al. 2008 Not Reported 172 v1.0 12.04.09 APPENDIX III AAOS BODIES THAT APPROVED THIS CLINICAL PRACTICE GUIDELINE Guidelines and Technology Oversight Committee The AAOS Guidelines and Technology Oversight Committee (GTOC) consist of sixteen AAOS members. The overall purpose of this Committee is to oversee the development of the clinical practice guidelines, performance measures, health technology assessments and utilization guidelines. Evidence Based Practice Committee The AAOS Evidence Based Practice Committee (EBPC) consists of ten AAOS members. This Committee provides review, planning and oversight for all activities related to quality improvement in orthopaedic practice, including, but not limited to evidence-based guidelines, performance measures, and outcomes. Council on Research, Quality Assessment, and Technology To enhance the mission of the AAOS, the Council on Research, Quality Assessment, and Technology promotes the most ethically and scientifically sound basic, clinical, and translational research possible to ensure the future care for patients with musculoskeletal disorders. The Council also serves as the primary resource to educate its members, the public, and public policy makers regarding evidenced-based medical practice, orthopaedic devices and biologics, regulatory pathways and standards development, patient safety, occupational health, technology assessment, and other related areas of importance. The Council is comprised of the chairs of the AAOS Biological Implants, Biomedical Engineering, Evidence Based Practice, Guidelines and Technology Oversight, Occupational Health and Workers’ Compensation, Patient Safety, Research Development, and US Bone and Joint Decade committees. Also on the Council are the AAOS second vice-president, representatives of the Diversity Advisory Board, the Women's Health Issues Advisory Board, the Board of Specialty Societies (BOS), the Board of Councilors (BOC), the Communications Cabinet, the Orthopaedic Research Society (ORS), the Orthopedic Research and Education Foundation (OREF), and three members at large. Board of Directors The 17 member AAOS Board of Directors manages the affairs of the AAOS, sets policy, and determines and continually reassesses the Strategic Plan. 173 v1.0 12.04.09 DOCUMENTATION OF APPROVAL AAOS Work Group Draft Completed August 18, 2009 Peer Review Completed September 18, 2009 Public Commentary Completed November 12, 2009 AAOS Guidelines and Technology Oversight Committee December 2, 2009 AAOS Evidence Based Practice Committee December 2, 2009 AAOS Council on Research, Quality Assessment, and Technology December 2, 2009 AAOS Board of Directors December 4, 2009 174 v1.0 12.04.09 APPENDIX IV LITERATURE SEARCHES FOR PRIMARY STUDIES The literature searches were performed using the following databases. The full search strategies are listed below: PubMed EMBASE CINAHL The Cochrane Library The National Guidelines Clearinghouse TRIP Database - Guidelines All literature searches were supplemented with manual screening of bibliographies in publications accepted for inclusion into the evidence base. In addition, the bibliographies of recent review articles were searched for potentially relevant citations. PubMed was searched using the following strategy: (("Achilles Tendon"[mh] OR Achilles[tw]) AND ((("Tendon Injuries"[mh] OR injuries[sh] OR injur*[tiab] OR ruptur*[tiab] OR re-ruptur*[tiab] OR tears[tiab] OR torn[tiab] OR tear[tiab]) AND (diagnosis[sh] OR diagnos*[tw] OR "Magnetic Resonance Imaging"[mh] OR MRI[tiab] OR Ultrasonography[mh] OR sonograph*[tiab] OR ultrasound[tiab] OR radiograph*[tiab] OR Radiography[mh] OR x-ray[tiab] OR imaging[tiab] OR gap[tiab] OR "Thompson test"[tw] OR therapy[sh] OR treated[tiab] OR treatment*[tiab] OR brace[tiab] OR bracing[tiab] OR cast[tiab] OR casting[tiab] OR casts[tw] OR "Casts, Surgical"[mh] OR immobiliz*[tiab] OR surgery[tiab] OR surgical*[tiab] OR operati*[tiab] OR repair*[tiab] OR reconstruct*[tiab] OR nonoperativ*[tiab] OR nonoperativ*[tiab] OR "weight bearing"[tiab] OR "Recovery of Function"[mh] OR "Physical Therapy Modalities"[mh] OR physiotherapy[tiab] OR Anticoagulants[pa])) OR ((repair*[tiab] OR surgery[tiab] OR surgery[sh] OR surgical*[tiab] OR operati*[tiab] OR repair*[tiab] OR reconstruct*[tiab] OR postoperative*[tiab] OR postoperative*[tiab]) AND ("Physical Therapy Modalities"[mh] OR physiotherapy[tiab] OR brace[tiab] OR bracing[tiab] OR cast[tiab] OR casting[tiab] OR casts[tw] OR "Casts, Surgical"[mh] OR immobiliz*[tiab] OR low-impact[tiab] OR activity[tiab] OR activities[tiab] OR "weight bearing"[tiab] OR weight bearing[tiab] OR "Recovery of Function"[mh])))) AND "1966"[PDat]:"2008"[PDat] AND “1”[EDat]:”2008/12/21”[EDAT] AND English[lang] AND (human[mh] OR in process[sb] OR publisher[sb]) NOT (comment[pt] OR editorial[pt] OR letter[pt] OR addresses[pt] OR news[pt] OR "newspaper article"[pt] OR “historical article”[pt] OR "case reports"[pt] OR "retrospective case study"[tw]) EMBASE was searched using the following strategy: ('Achilles tendon rupture'/de OR (('Achilles tendon'/de OR Achilles) AND ('tendon reconstruction'/de OR ((('tendon injury'/de OR injur* OR ruptur* OR reruptur* OR tears OR torn OR tear) AND (diagnos* OR 'nuclear magnetic resonance imaging'/exp OR mri OR 'ultrasound'/de OR ultrasound OR sonograph* OR radiograph* OR 'radiography'/de 175 v1.0 12.04.09 OR imaging OR gap OR 'thompson test' OR treated OR treatment* OR brace OR bracing OR cast OR casts OR 'plaster cast'/de OR 'walking aid'/de OR immobiliz* OR surgery OR surgical* OR operati* OR repair* OR reconstruct* OR nonoperativ* OR 'weight bearing'/de OR 'weight bearing' OR 'convalescence'/de OR 'physiotherapy'/exp OR physiotherapy OR 'anticoagulant agent'/exp)) OR ((repair* OR surgery OR surgical* OR operti* OR reconstruct* OR postoperative*) AND ('physiotherapy'/de OR physiotherapy OR brace OR bracing OR case OR casting OR casts OR 'plaster cast'/de OR 'walking aid'/de OR immobiliz* OR 'low impact' OR activity OR activities OR 'weight bearing'/de OR 'weight bearing' OR convalescence/de)))))) AND ([article]/lim OR [conference paper]/lim OR [review]/lim) AND [english]/lim AND [humans]/lim AND [embase]/lim NOT [22-12-2008]/sd CINAHL was searched using the following strategy: MM "Achilles Tendon" or Achilles and MM "tendon injuries" or ruptur* and ( PT “research” and LA English and PY 1966-2008 ) not (PT “editorial” or PT “letter” or PT “case study” or MM “case studies”) The Cochrane Library was searched using the following strategy: Achilles AND (injur* OR ruptur* OR re-ruptur* OR tears OR torn OR tear) The National Guidelines Clearinghouse was searched using the following strategy: Achilles tendon rupture The TRIP Database - Guidelines was searched using the following strategy: Achilles tendon rupture 176 v1.0 12.04.09 APPENDIX V STUDY ATTRITION FLOWCHART 4247 citations identified by literature search 1766 citations excluded 2481 abstracts screened for inclusion 2200 abstracts excluded 281 articles recalled for full text review 235 articles excluded 46 articles included 177 v1.0 12.04.09 APPENDIX VI DATA EXTRACTION ELEMENTS The data elements below were extracted into electronic forms in Microsoft® Access and Microsoft® Excel. The extracted information includes: Study Characteristics (for all relevant outcomes in a study) methods of randomization and allocation use of blinding (patient, caregiver, evaluator) funding source/conflict of interest duration of the study number of subjects and follow-up percentage experimental and control groups Patient Characteristics (for all treatment groups in a study) patient inclusion/exclusion criteria co-interventions (if used) and co-morbidities (if present) measures of disease severity Complications Results (for all relevant outcomes in a study) outcome measure is the outcome measure patient-oriented? validated? objective/subjective? duration at which outcome measure was evaluated statistic reported (for dichotomous results) mean value and measure and value of dispersion (continuous results) statistical test used, value of test statistic, and p-value verification of calculations 178 v1.0 12.04.09 APPENDIX VII JUDGING THE QUALITY OF DIAGNOSTIC STUDIES The QUADAS tool is used to identify sources of bias, variability, and the quality of reporting in studies of diagnostic accuracy. Fourteen questions answered “yes”, “no”, or “unclear” contribute to the QUADAS tool. There is no score derived from the use of the QUADAS tool. Was the spectrum of patient’s representative of the patients who will receive the test in practice? Were selection criteria clearly described? Is the reference standard likely to correctly classify the target condition? Is the time period between ref. standard and index test short enough to be reasonably sure that the target condition did not change between the two tests? Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis? Did patients receive the same reference standard regardless of the index test result? Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)? Was the execution of the index test described in sufficient detail to permit replication of the test? Was the execution of the reference standard described in sufficient detail to permit its replication? Were the index test results interpreted without knowledge of the results of the reference standard? Were the reference standard results interpreted without knowledge of the results of the index test? Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? Were uninterpretable/intermediate test results reported? Were withdrawals from the study explained? 179 v1.0 12.04.09 JUDGING THE QUALITY OF TREATMENT STUDIES RANDOMIZED CONTROLLED TRIALS Did the study employ stochastic randomization? Was there concealment of allocation? Were subjects blinded to the treatment they received? Were those who assessed/rated the patient’s outcomes blinded to the group to which the patients were assigned? Was there more than 80% follow-up for all patients in the control group and the experimental group on the outcome of interest? Did patients in the different study groups have similar levels of performance on ALL of the outcome variables at the time they were assigned to groups? For randomized crossover studies, was there evidence that the results obtained in the study’s two experimental groups (in period 1 and 2) did not differ? For randomized crossover studies, was there evidence that the results of the two control groups (in period 1 and 2) did not differ? PROSPECTIVE NON- RANDOMIZED CONTROLLED STUDIES Were the characteristics of patients in the different study groups comparable at the beginning of the study? Did patients in the different study groups have similar levels of performance on ALL of the outcome variables at baseline? Were all of the study’s groups concurrently treated? Was there more than 80% follow-up for all patients in the control group and the experimental group on the outcome of interest? Did the study avoid collecting control group data from one center and experimental group data from another? For crossover studies, was there evidence that the results obtained in the study’s two experimental groups (in period 1 and 2) did not differ? For crossover studies, was there evidence that the results of the two control groups (in period 1 and 2) did not differ? 180 v1.0 12.04.09 RETROSPECTIVE COMPARATIVE STUDIES Was there less than 20% difference in completion rates in the study’s groups? Were all of the study’s groups concurrently treated? Was the same treatment given to all patients enrolled in the experimental and Were the same laboratory tests, clinical findings, psychological instruments, etc. used to measure the outcomes in all of the study’s groups? Were the follow-up times in all of the study’s relevant groups approximately equal? Was there more than 80% follow-up for all patients in the control group and the experimental group on the outcome of interest? Did the study avoid collecting control group data from one center and experimental group data from another? Did patients in the different study groups have similar levels of performance on ALL of the outcome variables at the time they were assigned to groups? Were the characteristics of patients in the different study groups comparable at the beginning of the study? CASE SERIES Was enrollment in the study consecutive? Was there more than 80% follow-up for all patients on the outcome of interest? Were the same laboratory tests, clinical findings, psychological instruments, etc. used to measure the outcomes in all patients? Were the patients instructed/not given concomitant or adjuvant treatments? Were the follow-up times for all patients approximately equal? 181 v1.0 12.04.09 APPENDIX VIII FORM FOR ASSIGNING STRENGTH OF RECOMMENDATION (INTERVENTIONS) GUIDELINE RECOMMENDATION___________________________________ PRELIMINARY STRENGTH OF RECOMMENDATION:________________________________________ STEP 1: LIST BENEFITS AND HARMS Please list the benefits (as demonstrated by the systematic review) of the intervention Please list the harms (as demonstrated by the systematic review) of the intervention Please list the benefits for which the systematic review is not definitive Please list the harms for which the systematic review is not definitive STEP 2: IDENTIFY CRITICAL OUTCOMES Please circle the above outcomes that are critical for determining whether the intervention is beneficial and whether it is harmful Are data about critical outcomes lacking to such a degree that you would lower the preliminary strength of the recommendation? What is the resulting strength of recommendation? STEP 3: EVALUATE APPLICABILITY OF THE EVIDENCE Is the applicability of the evidence for any of the critical outcomes so low that substantially worse results are likely to be obtained in actual clinical practice? Please list the critical outcomes backed by evidence of doubtful applicability: Should the strength of recommendation be lowered because of low applicability? What is the resulting strength of recommendation? STEP 4: BALANCE BENEFITS AND HARMS Are there trade-offs between benefits and harms that alter the strength of recommendation obtained in STEP 3? What is the resulting strength of recommendation? 182 v1.0 12.04.09 STEP 5 CONSIDER STRENGTH OF EVIDENCE Does the strength of the existing evidence alter the strength of recommendation obtained in STEP 4? What is the resulting strength of recommendation? NOTE: Because we are not performing a formal cost analyses, you should only consider costs if their impact is substantial. 183 v1.0 12.04.09 APPENDIX IX VOTING BY THE NOMINAL GROUP TECHNIQUE Voting on guideline recommendations will be conducted using a modification of the nominal group technique (NGT), a method previously used in guideline development.12 Briefly each member of the guideline work group ranks his or her agreement with a guideline recommendation on a scale ranging from 1 to 9 (where 1 is “extremely inappropriate” and 9 is “extremely appropriate”). Consensus is obtained if the number of individuals who do not rate a measure as 7, 8, or 9 is statistically non-significant (as determined using the binomial distribution). Because the number of work group members who are allowed to dissent with the recommendation depends on statistical significance, the number of permissible dissenters varies with the size of the work group. The number of permissible dissenters for several work group sizes is given in the table below: Number of Permissible Dissenters Work group Size ≤3 Not allowed, statistical significance cannot be obtained 4-5 0 6-8 1 9 1 or 2 The NGT is conducted by first having members vote on a given recommendation without discussion. If the number of dissenters is “permissible”, the recommendation is adopted without further discussion. If the number of dissenters is not permissible, there is further discussion to see whether the disagreement(s) can be resolved. Three rounds of voting are held to attempt to resolve disagreements. If disagreements are not resolved after three voting rounds, no recommendation is adopted. 184 v1.0 12.04.09 APPENDIX X STRUCTURED PEER REVIEW FORM U Review of any AAOS confidential draft allows us to improve the overall guideline but does not imply endorsement by any given individual or any specialty society who participates in our review processes. The AAOS review process may result in changes to the documents; therefore, endorsement cannot be solicited until the AAOS Board of Directors officially approves the final guideline. U U U Reviewer Information: Name of Reviewer_________________________________________ Address_________________________________________________ City___________________ State_________________ Zip Code___________ Phone _____________________Fax ________________________ E-mail_______________________ Specialty Area/Discipline: _______________________________________ Work setting: _________________________________________________ Credentials: _________________________________________________ May we list you as a Peer Reviewer in the final Guidelines? Yes No Are you reviewing this guideline as a representative of a professional society? Yes No If yes, may we list your society as a reviewer of this guideline? Yes No Reviewer Instructions Please read and review this Draft Clinical Practice Guideline and its associated Technical Report with particular focus on your area of expertise. Your responses are confidential and will be used only to assess the validity, clarity, and accuracy of the interpretation of the evidence. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report. If you need more space than is provided, please attach additional pages. Please complete and return this form electronically to [email protected] or fax the form back to Jan Weis at (847) 823-9769. H H Thank you in advance for your time in completing this form and giving us your feedback. We value your input and greatly appreciate your efforts. Please send the completed form and comments by Month, Day, Year 185 v1.0 12.04.09 186 v1.0 12.04.09 COMMENTS Please provide a brief explanation of both your positive and negative answers in the preceding section. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report OVERALL ASSESSMENT Would you recommend these guidelines for use in practice? (check one) Strongly recommend _______ Recommend (with provisions or alterations) _______ Would not recommend _______ Unsure _______ COMMENTS: Please provide the reason(s) for your recommendation. 187 v1.0 12.04.09 APPENDIX XI PEER REVIEW PANEL Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization. Peer review of the draft guideline is completed by an outside Peer Review Panel. Outside peer reviewers are solicited for each AAOS guideline and consist of experts in the guideline’s topic area. These experts represent professional societies other than AAOS and are nominated by the guideline Work group prior to beginning work on the guideline. For this guideline, eleven outside peer review organizations were invited to review the draft guideline and all supporting documentation. Seven societies participated in the review of this guideline draft and explicitly consented to be listed as a peer review organization in this appendix. The organizations that reviewed the document and gave written consent to publication are listed below: American Academy of Family Practitioners American Academy of Physical Medicine and Rehabilitation American College of Foot and Ankle Surgeons American Orthopaedic Foot and Ankle Society American Orthopaedic Society for Sports Medicine American Physical Therapy Association American Podiatric Medical Association Individuals who participated in the peer review of this document and gave their explicit written consent to be listed as reviewers of this document are: U U Avrill Roy Berkman, MD Christopher R. Carcia, MD Michael Heggeness, MD Harvey Insler, MD John Kirkpatrick, MD Michael S. Lee, DPM, FACFA Angus McBryde Jr., MD Ariz R. Mehta, MD Lawrence Oloff, DPM Steven Raikin, MD Charles Reitman, MD John Richmond, MD Kevin Shea, MD Naomi Sheilds, MD Nelson F. Soohoo, MD Glenn Weinraub, DPM, FACFAS 188 v1.0 12.04.09 Again, participation in the AAOS guideline peer review process does not constitute an endorsement of the guideline by the participating organizations or the individuals listed above. PUBLIC COMMENTARY A period of public commentary follows the peer review of the draft guideline. If significant non-editorial changes are made to the document as a result of public commentary, these changes are also documented and forwarded to the AAOS bodies that approve the final guideline. The organizations that reviewed the document and consented to publication are listed below: German Society for Foot and Ankle Surgery (GFFC) Public commentators who gave explicit written consent to be listed in this document include the following: Laura Gehrig, MD Kurt F. Konkel, MD John McGraw COL, USAR, MC David Thordarson, MD Mathew Walther, MD Kristy Weber, MD For this guideline, outside specialty societies could post the confidential draft of the guideline to their “member only” website. The only society that submitted a compiled response as a result of this posting was the American Orthopaedic Foot and Ankle Society. Responses garnered from this posting were compiled by the specialty society and submitted as one succinct public commentary by a member of the AOFAS evidencebased medicine committee. Please contact the AOFAS for these member names since we do not have explicit written consent to publish the names of these members. Participation in the AAOS guideline public commentary review process does not constitute an endorsement of the guideline by the participating organizations or the individual listed nor does it is any way imply the reviewer supports this document. 189 v1.0 12.04.09 APPENDIX XII DESCRIPTION OF SYMBOLS USED IN TABLES Symbol OR 95% CI ○ ● op Description Odds Ratio = The odds in Group B divided by the odds in Group A, where the odds is the probability of the outcome occurring divided by the probability of the outcome not occurring. 95% Confidence Interval = A measure of uncertainty of the point estimate: if the trial were repeated an infinite number of times, then the 95% CI calculated for each trial would contain the true effect 95% of the time. An open circle in a Summary of Evidence Table indicates that the result is not statistically significant. A filled-in circle in a Summary of Evidence Table indicates that the result is statistically significant in favor of the listed treatment (in this example, in favor of op = operative treatment) 190 v1.0 12.04.09 APPENDIX XIII CONFLICT OF INTEREST Eric Michael Bluman, MD (Tacoma, WA): 4 (DePuy, A Johnson & Johnson Company). Submitted on: 08/23/2008 and last confirmed as accurate on 10/09/2008. Christopher P Chiodo, MD (Boston, MA): 1 (American Orthopaedic Foot and Ankle Society; Mass Ortho Association); 2 (Foot and Ankle International); 3 (Aircast(DJ); Arthrex, Inc); 4 (DePuy, A Johnson & Johnson Company); 5A (Smith & Nephew; Zimmer); 7 (DJ Orthopaedics; EBI; Carticept); 8 (Johnson & Johnson; Zimmer). Submitted on: 10/24/2008. Bruce E Cohen, MD (Charlotte, NC): 2 (Foot and Ankle International; Techniques in Foot and Ankle Surgery); 3 (DJ Orthopaedics; Wright Medical Technology, Inc); 4 (Arthrex, Inc); 5A (Wright Medical Technology, Inc.; Smith & Nephew); 7 (DJ Orthopaedics; Wright Medical Technology, Inc.); 9 (Lippincott). Submitted on: 05/18/2008. John E Femino, MD (Iowa City, IA): (n). Submitted on: 10/30/2008. Eric Giza, MD (Sacramento, CA): 5A (Arthrex, Inc). Submitted on: 02/13/2008. Mark Glazebrook, MD (Halifax,NS Canada): 2 (Foot and Ankle International); 5A (DePuy, A Johnson & Johnson Company; Linvatec); 7 (Arthrex, Inc; Biomimetic; DePuy, A Johnson & Johnson Company); 8 (Smith & Nephew; Stryker; Wright Medical Technology, Inc.). Submitted on: 11/04/2008. William Charles Watters III, MD: 1 (North American Spine Society; Work Loss Data Institute); 2 (The Spine Journal); 5A (Stryker; Intrinsic Therapeutics; MeKessen Health Care Solutions). 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