The Art of Orthopaedics - Thomas Jefferson University Hospitals
Transcription
The Art of Orthopaedics - Thomas Jefferson University Hospitals
The Art of Orthopaedics ORTHOPAEDIC OUTCOMES AND RESEARCH 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 A CONTENTS 2 T RANSFORMING CARE: AN OVERVIEW SPECIALTIES 4 COMPLEX SPINE 8 JOINT REVISION 14 HAND AND WRIST 20 MUSCULOSKELETAL ONCOLOGY 24 TRAUMA 28 ONGOING CLINICAL TRIALS B Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research A MESSAGE FROM THE CHAIR Dear Colleagues, I am pleased to share this Orthopaedic Outcomes and Research report, which highlights important clinical and research developments at Thomas Jefferson University Hospitals. This year’s report is titled Transforming Care because that is precisely what we are doing every day in Jefferson’s Department of Orthopaedic Surgery. In the pages ahead you will see the many ways that orthopaedic specialists at Jefferson are committed to clinical excellence, research and education of other practitioners in the field. Our clinicians and scientists — including experts from the Rothman Institute at Jefferson and the Philadelphia Hand Center at Jefferson — are intent on transforming findings from laboratory studies and clinical research projects into new medical and surgical techniques that will improve the delivery of care and enhance patient outcomes by every measure. Our research agenda is furthering the understanding of both ordinary and rare orthopaedic diseases, expanding diagnostic capabilities through the use of enhanced imaging techniques and novel biomarkers, and challenging conventional notions around orthopaedic surgery. Because of findings by our research team, for instance, certain patients undergoing orthopaedic surgery are now less likely to be placed on aggressive anticoagulation therapy or get a urinary catheter. Such seemingly simple changes are helping to improve the overall quality of care experienced by our patients. Jefferson is honored to be the largest orthopaedic program in the Delaware Valley. Last year, through the collective experience of our orthopedic specialists, more than 36,000 surgical procedures were performed in eight specialty areas — hip and knee, spine, hand and wrist, musculoskeletal oncology, shoulder and elbow, sports medicine, foot and ankle and trauma. U.S.News & World Report ranks Jefferson’s orthopaedic program among the top 10 in the country. I invite you to read this Outcomes and Research report to learn how Jefferson orthopaedic clinicians and scientists are Transforming Care through the development of new therapies, more effective clinical pathways and best practice methodologies. More information about the orthopaedic services available at Jefferson can be found at our website, Jefferson.edu/Orthopedic. To refer a patient, please call 215-503-8888 or have your patient call 1-800-JEFF-NOW. Thank you for your interest. I wish you much happiness and success in the New Year. Alexander R. Vaccaro, MD, PhD Richard H. Rothman Professor and Chair Department of Orthopaedic Surgery Thomas Jefferson University Hospitals Sidney Kimmel Medical College at Thomas Jefferson University 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 Orthopaedic care is central to the goal of keeping people active throughout every decade of life. Whether the patient is a student athlete struggling with an injury, a worker who has suffered a fall, or an octogenarian with degenerative disc disease, the orthopaedic team at Jefferson’s Department of Orthopaedic Surgery is committed to helping the patient return to as full function as possible, free of pain. TRANSFORMING CARE an overview This Orthopaedic Outcomes and Research report, titled Transforming Care, illustrates why so many patients turn to Jefferson for care. The orthopaedics team — which includes specialists from the Rothman Institute at Jefferson and the Philadelphia Hand Center at Jefferson — utilize the latest in imaging and diagnostic technologies, surgical and nonsurgical techniques, implant materials, pain management, rehabilitation therapies and prevention measures to deliver the highest level of care. U.S.News & World Report ranks Jefferson’s orthopaedic program Number 8 in the nation. Clinical practices are informed by a full research agenda that reaches from the laboratory to the bedside and clinic. Jefferson researchers are exploring the biology of orthopaedic diseases right down to specific molecules and genes; testing new surgical materials that can lead to better results; and taking part in studies of drug therapies and surgical techniques that enhance recovery and quality of life. Patients coming to Jefferson have access to clinical trials often found nowhere else in the region. 2 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research This report highlights recently published research from five of the eight specialty areas of orthopaedic care at Jefferson: •J oint Replacement (Or Hip and Knee). Jefferson researchers devised a risk stratification system for assessing whether surgical patients are at high risk for pulmonary embolism and in need of more aggressive anticoagulation prophylaxis. • Spine. Amid a growing public health concern over opioid abuse, researchers evaluated whether opioid medications help improve outcomes for patients with back pain. • Hand and Wrist. Researchers measured screws commonly used for finger surgery to determine whether they are a good anatomical fit. They also studied design aspects of volar locking plates. •M usculoskeletal Oncology. Case reports on patients undergoing resection and reconstruction for pelvis tumors demonstrated innovative approaches to surgery. • Trauma. Researchers led a multi-center study that is helping to understand a particular type of femur fracture that seems to be occurring more frequently. Those studies and others detailed in this report illustrate the many ways that Jefferson’s Department of Orthopaedic Surgery is working simultaneously to advance research and improve patient outcomes. The goal of Transforming Care is being realized. By the Numbers January – September 2014 9,174 2,762 2,279 4,950 JOINT SURGERIES SHOULDER AND ELBOW SURGERIES SPINAL SURGERIES SPORTS MEDICINE CASES 7,268 2,033 366 326 HAND AND WRIST SURGERIES FOOT AND ANKLE SURGERIES TRAUMA CASES MUSCULOSKELETAL ONCOLOGY CASES 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 3 COMPLEX SPINE 4 WITH THE POPULATION AGING, THE NEED TO IDENTIFY THE BEST SURGICAL AND NONSURGICAL APPROACHES TO TREATING SPINAL DISORDERS HAS NEVER BEEN GREATER. SERVICES • Treatment for cervical, thoracic and lumbosacral spinal conditions • Treatment for scoliosis/ spinal deformities, spondylolisthesis, spinal cord injury/ trauma, spinal infections and spinal tumors • Minimally invasive techniques and imageguided technology • Comprehensive treatment of disc disease, including disc replacement Jefferson spine surgeons are leaders in the treatment of traumatic and degenerative spine disorders, from spinal cord injury and tumors to herniated discs and spinal stenosis. They routinely treat complex spine issues and are leaders in the use of minimally invasive techniques for cases that could benefit from that approach. Patients arriving at Jefferson in an emergency situation benefit from the fact that the hospital is both a designated Level 1 Trauma Center and a federally designated spinal cord injury center. Through the collective experience of our orthopaedic spine specialists and under the supervision of co-directors Alan Hilibrand, MD and Alexander Vaccaro, MD, PhD, more than 2,500 surgeries were performed in 2014. Pain and loss of mobility are major concerns of spinal patients, and Jefferson’s multidiscipline approach to treatment planning includes both attention to optimizing pain management and enhancing recovery through rehabilitative therapy. All care, whether emergency or non-urgent, delivered by Jefferson’s orthopaedic spine specialists is informed by a robust research agenda that includes the testing of new diagnostic and surgical techniques, as well as ways to better manage spinal conditions nonsurgically. Here are two recent studies aimed at improving patient outcomes: Comparison of Open and Minimally Invasive Techniques for Posterior Lumbar Instrumentation and Fusion After Anterior Lumbar Interbody Fusion It is sometimes automatically assumed that minimally invasive surgery (MIS) is superior to a conventional approach. Minimally invasive techniques for spinal fusion would seem to provide an advantage in reducing paraspinal muscle injury, osteoligamentous destabilization and surgical morbidity, which can result in faster recovery for patients. But such assumptions need to be objectively assessed to make sure that new minimally invasive techniques can accomplish their surgical objectives while not compromising surgical outcomes or increasing complications for patients. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 5 COMPLEX SPINE Surgery Volume YTD 2014 Source: Jefferson internal data Calendar YTD through September YTD 2013 2,279 2,255 TOTAL 2013 Does Opioid Pain Medication Use Affect the Outcome of Patients with Lumbar Disc Herniation? 3,034 1,000 1,500 2,0002,500 3,000 In a study published in The Spine Journal, a Jefferson research team headed by Christopher Kepler, MD, designed a case-controlled retrospective study to analyze whether using MIS for posterior fusion and instrumentation following open anterior lumbar interbody fusion (ALIF) was superior to using an open approach for pedicle screw placement and decompression. The study involved 81 patients who underwent a combined open and MIS operation and 81 patients who had traditional open surgery for both stages of the ALIF operation. Among the findings: •Following ALIF, MIS posterior fusion techniques resulted in less blood loss, less need for transfusions and shorter hospital stays compared to an open approach. The average hospital stay was reduced from 5.3 days to 4.4 days. he advantage of MIS over open surgery was less • T apparent in patients who underwent posterior decompression at the time of instrumentation. •Fluoroscopy time was significantly greater with MIS — 1.5 minutes compared to 0.2 minutes for the open group. • There were no significant differences between the MIS and open group when it came to infection and other complications, such as misplaced pedicle screws, a need for screw revision or pulmonary embolus. “These data support the notion that MIS surgery has reduced operative morbidity and faster early recovery when used for posterior instrumentation but may not have significant benefits when a concomitant decompression is necessary,” the researchers concluded. “It should be acknowledged that benefits of MIS come at the cost of significantly higher use of ionizing radiation.” The researchers said that larger studies with longer follow up are needed to determine long-term outcomes and complications related to MIS techniques compared to traditional surgical approaches. 6 Opioid medications are often used for treatment of both acute and chronic back pain. Potential benefits of opioid use in patients with severe unremitting pain include decreased pain levels, functional improvement and improved mood and social function. However, there are significant societal concerns about the potential dangers of opioids, including side effects such as altered mental status, abuse of drugs, diversion of drugs to individuals other than the patient, and overdose. Also, there is the possibility that ongoing use of opioids to control pain could lead to tolerance and a need for escalating doses and ultimately, poorer outcomes when surgical treatment is indicated. Despite such concerns, the use of opioid medication compared to nonpain medication (anti-inflammatory agents and muscle relaxants) is growing in the Medicare population. Jefferson is part of a multi-center study called the SPORT trial that is evaluating surgical versus nonsurgical treatment of common lumbar degenerative conditions. As part of that effort, the researchers, headed by Kris Radcliff, MD, looked at the impact of opioids on outcomes of surgical and nonsurgical treatment of lumbar disc herniation. The study helped answer several important clinical questions. Do patients who take opioids fare better or worse over the long haul than those who don’t? Are they able to avoid surgery? Do they become dependent on opioids? The study, published in Spine, compared 520 patients who did not receive opioids to 542 patients who did. The patients were assessed periodically — at baseline, three weeks, six weeks, six months, one year, two years, three years and four years following surgery. Primary outcome measures included the bodily pain (BP), physical functions (PF) and mental component summary (MCS) domains of the SF-36 and the AAOS version of the Oswestry Disability Index (ODI). Patient self-reports and several standardized pain severity assessment scales were used as secondary outcome measures. Among the findings: •Approximately 40 to 49 percent of study participants were treated with opioid analgesics during the pre-enrollment period and 35 to 45 percent during the course of the study. •Despite taking stronger pain medication, patients taking opioids had more pain and poorer quality of life and were more likely to report that their pain symptoms were worsening. They were more likely to Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research 5 7% 6% 5% 0 1 year 2 years 3 years 4 years Figure 1. There was no change in outcome between patients who were treated with opioids versus patients who were not treated with opioids over the four-year study period. Primary Outcomes Over Time for Non-Narcotics and Had-Narcotics Use at Baseline BODILY PAIN PHYSICAL FUNCTION OSWESTRY Surgery p-value = 0.96 Non-operative p-value = 0.078 Interaction p-value = 0.15 Surgery p-value = 0.84 Non-operative p-value = 0.36 Interaction p-value = 0.55 Surgery p-value = 0.84 Non-operative p-value = 0.30 Interaction p-value = 0.34 30 40 50 60 Non-Operative: Had-Narcotics Non-Operative: Non-Narcotics 20 10 0 Adjusted Mean Different from Baseline Surgery: Had-Narcotics Surgery: Non-Narcotics 0 3 6 12 24 36 Months from Baseline 48 0 3 6 12 24 36 Months from Baseline 48 0 3 6 12 24 36 Months from Baseline 48 Figure 2. After four years, 16 percent of patients who were taking opioids at study enrollment were taking opioids at time of study conclusion. Only 5 percent of patients who were opioid naive at the time of study enrollment and were treated with opioids during the study period were taking opioids at time of study conclusion. Does Opioid Pain Medication Use Affect the Outcomes for Patients with Lumbar Disc Herniation? 25 25% 20 21% 17% 15 16% 10 8% 5 7% 6% 5% 0 1 year 2 years 3 years 4 years Source: Kris Radcliff, MD, Thomas Jefferson University Hospitals. have disability (18 versus 9 percent), have filed a compensation claim (24 versus 13 percent) and smoke (29 versus 19 percent) than patients not taking opioids at the start of the study. They also tended to be heavier and less educated. and quality of life between the opioid and non-opioid groups. •The incidence of opioid use at four years was 16 percent among patients who were using opioids at baseline and 5 percent among those who were not. 60 50 40 30 20 10 Adjusted Mean Different from Baseline •A higher percentage of opioid patients Surgery: Had-Narcotics Non-Operative: Had-Narcotics Surgery: Non-Narcotics Non-Operative: underwent surgery (75 percent) compared to Non-Narcotics “Our results indicate no significant improvement in non-opioid patients (59 percent). outcomes associated with OSWESTRY opioid medication in the BODILY PAIN PHYSICAL FUNCTION treatment of lumbar disc herniation whether treated surgically or nonsurgically,” the authors concluded. • Patients who initially were treated nonsurgically were “Further study is required to determine if the transient more likely to ultimately get surgery if they were taking pain relief offsets the risks of opioid addiction and opioids than if they didn’t take the drugs (45 versus overdose since there is no long-term benefit of opioid 31 percent), suggesting that opioid medication did not medications to patients.” relieve lower back pain enough to avoid surgery. Surgery p-value = 0.96 Non-operative p-value = 0.078 Interaction p-value = 0.15 Surgery p-value = 0.84 Non-operative p-value = 0.36 Interaction p-value = 0.55 Based on the findings, Jefferson spine surgeons now minimize the48use0of3 6opioids in 24 patients36who have 24 36 12 48 Months from Baseline Months from problems that might benefit fromBaseline surgical treatment. 0 • At four-year follow up, there were no significant differences in measures of pain, degree of0 disability 3 6 12 0 3 6 12 24 36 48 Months from Baseline Surgery p-value = 0.84 Non-operative p-value = 0.30 Interaction p-value = 0.34 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 7 JOINT REVISION 8 JEFFERSON’S ORTHOPAEDIC SPECIALISTS HELP SET STANDARDS OF CARE FOR PATIENTS UNDERGOING HIP OR KNEE ARTHROPLASTY. SERVICES • Anterior-approach total hip replacement • Minimally invasive hip and knee replacement • Custom knee replacement • Adult joint reconstruction • Hip resurfacing • Partial knee replacement • Treatment of hip and knee disorders in young adults • Rapid-recovery surgery • Computer-assisted surgery • Pelvic reconstruction • Pelvic osteotomy and hip-impingement surgery • Joint preservation procedures At Jefferson, physicians continually explore ways to refine surgical techniques for primary and revision total joint arthroplasty (TJA) and challenge conventional thinking on how best to achieve outstanding outcomes for patients. Through the collective experience of our orthopaedic specialists, more than 2,500 TJA surgeries were performed in 2014, a number that speaks to the outstanding reputation of the hip and knee team. In addition to their clinical work, Jefferson hip and knee specialists made significant contributions to the surgical literature by expanding knowledge on the prevention of pulmonary emboli, the use of urinary catheters with spinal anesthesia and identification of periprosthetic joint infection using novel biomarkers. Here is a look at that research: Symptomatic Pulmonary Embolus After Joint Arthroplasty: Stratification of Risk Factors Prophylaxis for pulmonary embolism (PE) after total joint arthroplasty (TJA) presents the clinical dilemma of balancing the risk of postoperative thrombotic risk and anticoagulation-related complications such as bleeding, hematoma formation and infection. It would be helpful to have an evidence-based preoperative risk stratification system in place to evaluate whether patients undergoing TJA are at increased risk for thrombosis or bleeding so that prophylaxis therapy could be better tailored to an individual’s needs. To identify what specific factors put patients at risk for PE, Jefferson researchers, headed by Javad Parvizi, MD, conducted a retrospective review of 26,391 primary and revision TJAs performed at the hospital between January 2000 and April 2011 and included in an internal electronic database. Of those, 24,567 patients received warfarin prophylaxis for six weeks and 1,824 received 325 mg. aspirin twice daily. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 9 JOINT REVISION Surgery Volume Source: Jefferson internal data Calendar YTD through September YTD 2014 YTD 2013 Based on their analysis, they developed a classification system of low, medium and high risk. (See p. 10 and 11) 9,174 6,775 TOTAL 2013 6,000 7,000 8,000 9,000 10,000 10,849 11,000 “The risk stratification system has been further studied for validation by using the National Inpatient Sample database,” Dr. Parvizi said, “and it has been adopted for use at Jefferson.” The research team also is developing a mobile application that doctors everywhere could use to rank their patient’s risk for PE prior to surgery as a means to determine the best anticoagulation prophylaxis. Among the overall findings: •T he overall risk of postoperative symptomatic PE after primary and revision TJA was 1.1 percent. • The risk of fatal PE was 0.02 percent. •P atients who were obese, (a Body Mass Index (BMI)> 30 Kg/m2), underdoing knee procedures, had multiple medical comorbidities as reflected in an elevated score on the Charlson Comorbidity Index, or had chronic pulmonary disease, atrial fibrillation, anemia, depression or postoperative deep vein thrombosis were at greater risk of developing a postoperative PE. “Although the goal of our study was to identify risk factors associated with postoperative symptomatic PE development in patients undergoing TJA, the ultimate purpose of this study is to use this information in making clinical choices regarding thromboprophylaxis,” the researchers reported. Aspirin: An Alternative for Pulmonary Embolism Prophylaxis after Arthroplasty? It is not clear what drug is most effective in preventing venous thromboembolism (VTE) following TJA. Both warfarin and aspirin are used, but the debate over how best to prevent embolism while minimizing bleeding remains unresolved. Even though morbidity and mortality associated with PE have decreased dramatically in recent years, orthopaedic surgeons still worry about the risk of PE. To gain insight into the issue, Jefferson researchers utilized their database to review information on 28,923 patients who underwent either primary or revision arthroplasty at Jefferson from January 2000 to June 2012 and who had been given either aspirin (325 mg; twice daily, 2,800 patients) or warfarin (dosing varied, 26,123 patients) prophylaxis. PULMONARY EMBOLISM (PE) RISK STRATIFICATION CRITERIA Risk Factor Points P-Value Knee Surgery 5 <0.001 Charlson Comorbidity Index (CCI) 1xCCI Atrial Fibrillation 4 <0.001 Postoperative DVT 14 <0.001 Chronic Obstructive Pulmonary Disease 2 0.006 Anemia 2 <0.001 Depression 2 0.012 0.001 Body Mass Index (BMI) ≤ 25 0 25 to 30 1 0.035 > 30 2 <0.001 Source: Javad Parvizi, MD, Thomas Jefferson University Hospitals. 10 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research reference Pulmonary Embolism Risk Stratification Scale LOW RISK PE CATEGORY: < 7 POINTS Cumulative Risk in Each Group Patients in Risk Group (% of total) Total Score % Risk of PE 0 0% 743 0 1 0% 1423 0 Patients 2382 PEs 2 0.3% 3 0.3% 4 0.3% 2534 5 0.6% 1709 11 6 0.7% 1667 12 0.35% 2866 13,324 (50.4%) 7 10 PEs in Each Risk Group (% of total) 47 (16.7%) 7 Total Score % Risk of PE Patients Patients in Risk Group (% of total) PEs 7 1.1% 2094 22 8 1.2% 2847 34 9 1.3% 2934 37 10 1.6% 2062 34 11 1.6% 12 2.6% 545 13 2.4% 373 9 1.4% 1048 12,474 (47.3%) 17 14 14 1.6% 318 5 15 2.8% 253 7 PEs in Each Risk Group (% of total) Patients in Risk Group (% of total) Total Score % Risk of PE 16 4.3% 187 8 17 5.8% 138 8 Patients PEs 18 1.8% 56 1 19 5.0% 20 1 20 4.5% 22 179 (63.7%) 21 22.2% 9.3% 27 PEs in Each Risk Group (% of total) 6 22 23.3% 30 23 12.1% 33 4 7 24 21.6% 37 8 25 23.8% 21 5 26 28.6% 22 6 Medium Risk category defined as 7–15 points using our stratification scale • Cumulative risk of PE in this group = 1.4 percent •A ccounts for 179 (63.7 percent) of the total PEs in our cohort High Risk category Defined as >15 points using our stratification scale •C umulative risk of PE in this group = 9.3 percent • 593 (2.3 percent) of our TJA patients fell into this high risk group 1 593 (2.3%) • Accounts for 47 (16.7 percent) of the total PEs in our cohort • 1 2,474 (47.3 percent) of our TJA patients fell into this medium risk group HIGH RISK PE CATEGORY: > 15 POINTS Cumulative Risk in Each Group umulative risk of •C PE in this group = 0.35 percent • 1 3,324 (50.4 percent) of our TJA patients fell into this low risk group MEDIUM RISK PE CATEGORY: 7–15 POINTS Cumulative Risk in Each Group Low Risk category defined as <7 points using our stratification scale 55 (19.6%) • Accounts for 55 (19.6 percent) of the total PEs in our cohort Source: Javad Parvizi, MD, Thomas Jefferson University Hospitals. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 11 JOINT REVISION The study, published in Clinical Orthopaedics and Related Research, found that: •T he overall symptomatic PE rate was lower in patients receiving aspirin therapy (0.14 percent) than in patients receiving warfarin (1.07 percent). •T he rate of symptomatic DVT was 0.29 percent in the aspirin group, compared to 0.99 percent in the warfarin group. • Patients who received aspirin had shorter hospital stays on average — 2.48 days versus 4.08 days. •W hile bleeding and infection rates did not significantly differ between the two groups, the incidence of wound-related problems was lower when aspirin was used. The researchers concluded that for many TJA patients, aspirin can serve as an effective and safe alternative to warfarin, which can be difficult to dose. “The clinical success of less aggressive protocols in conjunction with an increasing number of young, healthy patients who are undergoing hip and knee arthroplasties seem to indicate that aspirin can be an adequate method of chemical anticoagulation in selected patients after orthopaedic surgeries,” the researchers reported. They noted that aspirin “is well tolerated, inexpensive and easy to administer.” Spinal Anesthesia: Should Everyone Receive a Urinary Catheter? The use of neuraxial anesthesia, commonly employed for elective joint arthroplasty, is considered to be an indication for the use of an indwelling urinary catheter. The rationale is that spinal anesthesia can result in the loss of the ability to sense bladder distention, which can lead to bladder dysfunction. While solving one problem, however, catheters can cause other problems, including urinary tract infection. Currently there is no standard protocol for the implementation and maintenance of indwelling catheters for elective joint arthroplasty. But at many institutions catheters are routinely used since reports indicate that roughly one in five patients could have problems with urinary retention. Jefferson researchers set out to evaluate the usefulness of indwelling catheters in preventing urinary retention by randomly assigning 207 consecutive patients undergoing total hip arthroplasty to either receive a urinary catheter or not to receive a catheter but be monitored for urinary retention. If needed, the group being monitored received straight catheterization for up to two times prior to the insertion of an indwelling catheter. The study, published in The Journal of Bone and Joint Surgery, found that: Based on the study results, Jefferson hip and knee surgeons are now relying more on aspirin as the preferred choice for thromboprophylaxis. 12 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research •T he rate of urinary retention was 9.6 percent without the use of an indwelling catheter, a rate much lower than previous reports in the literature. •N ine patients in the non-catheter group and three in the catheter group (following removal of the catheter) required straight catheterization. •T hree patients in the catheter group and none in the non-catheter group developed urinary tract infection. “Patients undergoing total hip arthroplasty under spinal anesthesia appear to be at low risk for urinary retention,” the researchers, headed by William Hozack, MD, wrote. “Thus, a routine indwelling catheter is not required for such patients.” The researchers said that further research could help identify whether certain subsets of patients might benefit from placement of a urinary catheter. Based on the study findings, Jefferson joint surgeons no longer routinely use urinary catheters in patients receiving joint replacement under spinal anesthesia. Diagnosing Perioprosthetic Joint Infection: Has the Era of the Biomarker Arrived? The diagnosis of perioprosthetic joint infection (PJI) remains a serious clinical challenge. The diagnostic difficulty is caused by a variety of factors — the absence of clinical signs and symptoms, the relative lack of accurate laboratory tests and difficulties in isolation of pathogens by culture because of prior antibiotic therapy and existence in a biofilm form. The Musculoskeletal Infection Society (MSIS) recently responded to this diagnostic difficulty by developing a multi-prong definition for PJI. Jefferson researchers have been studying whether biomarkers found in the synovial fluid could have a role in diagnosis of PJI, perhaps helping to identify cases promptly so that appropriate treatments could be initiated. To test the usefulness of 16 biomarkers, a research team headed by Carl Deirmengian, MD, collected synovial fluid from 95 patients who were being evaluated for a revision hip or knee arthroplasty, including some patients with systemic inflammatory disease and those already taking antibiotics. They used the MSIS definition to classify 29 PJIs and 66 aseptic joints. Synovial fluid samples were then tested by immunoassay for 16 biomarkers. The biomarkers were evaluated for sensitivity and specificity to determine if they were good predictors of PJI. Among the results: • Five biomarkers — including human alpha defensin 1-3, Neutrophil elastase 2, bactericidal/permeabilityincreasing protein, neutrophil gelatinase-associated lipocalin, and lactoferrin — correctly predicted the MSIS classification of all patients in the study with 100 percent sensitivity and specificity for the diagnosis of PJI. •E ight other biomarkers demonstrated excellent diagnostic strength. “Considering that these biomarkers match the results of the more complex MSIS definition of PJI, we believe that synovial fluid biomarkers can be a valuable addition to the methods utilized for the diagnosis of infection,” the researchers concluded. Jefferson researchers have been studying the biomarkers for 11 years. A commercial test for PJI called Synovosure, which combines alpha defensin and synovial C-reactive protein, is now being manufactured by CD Diagnostics. Based on study results, Jefferson hip and knee surgeons are now relying more on aspirin as the preferred choice for thromboprophylaxis. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 13 HAND AND WRIST 14 THE HAND IS A COMPLEX STRUCTURE INVOLVING A SYSTEM OF MULTIPLE MOVING PARTS. IT IS ONE OF THE MOST INTRICATE AND DELICATE PARTS OF THE BODY AND THE CENTER FOR ONE OF THE BODY’S FIVE SENSES, TOUCH. SERVICES • Hand and wrist surgery • Hand and wrist arthroscopy • Upper-extremity surgery • Microvascular surgery • Hand arthritis surgery • Brachial plexus reconstruction • Treatment of ligament and tendon disorders of the hand and wrist • Treatment of carpal and cubital tunnel syndromes • Treatment of Dupuytren’s disease • Treatment of complex nerve conditions • Treatment of hand and wrist sports injuries • Joint reconstruction for thumb arthritis • Minimally invasive nerve surgery • Joint replacement for hand arthritis Successful treatment of injuries and disorders involving the hand, wrist and forearm requires an understanding of how the many ligaments, tendons, muscle, joints and bones work together to provide good function and flexibility. An injury to one part can affect the working of the whole, causing pain and disability. Jefferson’s Department of Orthopaedic Surgery draws on the expertise of hand specialists from the Philadelphia Hand Center at Jefferson and the Rothman Institute at Jefferson. They are leaders in the treatment of hand arthritis, sports injuries, complex nerve conditions and carpal tunnel syndrome, to name just a few of their specialty services. The hand surgeons, working along with basic scientists, are also widely published researchers on both the mechanics and biology of hand disorders and injuries, furthering the understanding of key issues such as scar formation. They make frequent contributions to the literature on best practices for the medical and surgical management of patients, new surgical techniques and the efficacy of new implant materials and designs. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 15 HAND AND WRIST Surgery Volume YTD 2014 Source: Jefferson internal data Calendar YTD through September YTD 2013 7,268 6,634 TOTAL 2013 6,000 Radiation Exposure to Hand Surgeons’ Hands: A Practical Comparison of Large and Mini C-Arm Fluoroscopy 7,000 8,000 8,604 9,000 Here is a look at some of their recent research findings: Distal Radius Volar Locking Plate Design and Associated Vulnerability of the Flexor Pollicis Longus The treatment of distal radius fractures has evolved considerably over the past decade because of advancements in implant technology and surgical techniques. Since its introduction in 2000, the volar locking distal radius plate (VLP) has become the workhorse for the treatment of unstable distal radius fracture. However, despite its popularity, VLP fixation predisposes patients to specific risks and complications, including flexor pollicis longus (FPL) tendon rupture, which occurs in about 2 percent of cases. Jefferson researchers, A. Lee Osterman, MD, and Sidney M. Jacoby, MD, conducted a morphometric study to determine whether VLP design was a factor in FPL injury. They dissected 10 frozen cadaver tissue samples to identify the path of the FPL in relationship to the distal radius at the watershed line. Five VLP designs were then fixed to each specimen based on their anatomic fit, and slid distally until the distal edge of the plate reached the watershed line. Fluoroscopy was used to evaluate the positioning of each plate. Intraoperative imaging modalities are becoming an important and more routine part of orthopaedic practice. Surgeons now have access to both small and large fluoroscopic units with various specifications and functionality. Many hand surgeons have moved to the use of a mini C-arm fluoroscopy unit for a variety of reasons: the mini unit is easier to use in a smaller anatomical region such as the hand; the surgeon can operate the unit independently without the need for a radiology technologist; it takes up less space in the operating room; and it costs less than a larger unit. There is debate, however, over whether the mini C-arm offers an advantage over a larger unit in terms of radiation exposure. Studies have shown that the mini C-arm creates less scatter than the large C-arm with respect to ionizing radiation, but it’s not clear whether the smaller arm exposes the surgeon to more radiation because the surgeon’s hand is close to the operating unit. Jefferson researchers Charles Leinberry, MD, and Asif Ilyas, MD, designed a study to compute radiation exposure to hand surgeons’ hands with the large C-arm unit versus the mini arm. Two hand surgeons monitored radiation exposure to their hands with a ring dosimeter over a 14-month period. A total of 160 consecutive cases were included in the analysis. One surgeon performed 71 cases using the large C-arm unit and the other surgeon performed 89 cases using the mini unit. For each case, fluoroscopic time, the output displayed by the unit, radiation by time, and ring dosimeter absorptions were recorded and analyzed. Among the findings: The researchers also evaluated the shape of each of the five plates, in particular thickness, to evaluate native flexor tendon anatomy proximity. “Despite optimal plate placement, various VLP designs were observed to have prominent profiles volar to the watershed line,” the researchers reported in Journal of Hand Surgery (American Volume). “These results raise concerns regarding impingement between all of the analyzed VLP designs and the FPL,” they reported. “This study may help guide both implant design considerations and assist the surgeon in better understanding implant morphology as it relates to iatrogenic flexor tendon injury.” 16 •T he median fluoroscopic time per case using the large unit was 38 seconds, compared to 88 seconds for the mini C-arm. The added time may be because it took the surgeon more time to manipulate the small arm compared to the large one. •T he median output of radiation displayed by the large C-arm was 0.7 mGy/case, compared to 10.1 mGy/ case for the mini C-arm. •W ith output as a product of time, the median calculated values were 0.02 mGy/second for the large C-arm group compared to 0.28 mGy/s for the mini C-arm group. Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research •C umulative ring dosimeter absorption to the surgeon’s hands was 380 mrem for the 71 cases in the large C-arm group versus 1,000 mrem for the 89 cases in the mini C-arm group. “The mini C-arm unit delivered a greater radiation exposure to the hands of the surgeon,” the researchers concluded in a report in the Journal of Hand Surgery (American Volume). “In our model, the use of the mini C-arm resulted in more than a 10-fold increase in the rate of output and approximately double the dosimeter absorption to the surgeons’ hands compared with the large C-arm.” A B C D While the surgeons’ cumulative radiation exposure to their hands remained well below the internationally recommended maximum exposure level of 50,000 mrem to the extremities per year, the added exposure that comes with the use of the mini C-arm for fluoroscopy is worth considering, the researchers said. “Surgeons should be aware of their hands’ locations during fluoroscopy and take precautions to limit fluoroscopic time and radiation exposure,” they recommended. Four-corner Arthrodesis with a Radiolucent Locking Dorsal Circular Plate: Technique and Outcomes Scaphoid excision and four-corner arthrodesis (FCA) is an acceptable motion sparing procedure used to treat wrist arthritis. Fixation methods for the procedure vary and include the use of K-wires, staples and headless compression screws. Dorsal circular plates were developed with the idea that they could allow earlier range of motion while limiting postoperative stiffness, but results have been somewhat discouraging. More recently, locking dorsal circular plates have come into use, and the Xpode® cup is the first in the class to be composed of radiolucent polyether-ether-ketone. The Xpode® (made by TriMed Inc.) is designed to allow for more accurate radiographic assessment of cup placement intraoperatively as well as union postoperatively, compared to stainless steel models. The new device also provides elasticity similar to cortical bone. To study the efficacy of the Xpode® cup for FCA, Jefferson researchers, Sidney M. Jacoby, MD, and Mark S. Rekant, MD, reviewed the cases of all patients who underwent FCA with the device between January 1, 2008 and December 31, 2012. Twenty-six procedures Radiographs sequentially reveal increasing osseous fusion mass in the same patient over time (beginning with immediate post-operative image A through final follow up image D). (24 patients) were identified, and the patients were contacted and asked to return to the clinic for clinical and radiographic follow up. Among the findings, reported in Hand, were: •O ne patient required full wrist fusion following the initial procedure. Arthrodesis was successfully achieved in 20 of the other 25 wrists (80 percent). •E leven patients (13 wrists) returned to the clinic for follow-up at an average time of 28 months postoperatively. For those patients, mean wrist extension improved from 30 degrees to 47 degrees, and flexion decreased from 33 degrees to 23 degrees. •A t follow up, the average grip strength was 77 percent of the uninjured side. •P atient-Rated Wrist Evaluation (PRWE) scores for pain and function were 19.7 out of a possible 50 and 17.1/50 respectively. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 17 HAND AND WRIST •F ive patients underwent additional operations (two hardware removals, two contracture releases, and one distal radial ulnar joint arthroplasty). “The present study demonstrates an 80 percent fusion rate following scaphoid excision and fourcorner arthrodesis using the Xpode® cup, as well as acceptable pain and function outcomes at early follow-up,” the researchers concluded. “As a salvage procedure the Xpode® cup is a viable implant option for degenerative and posttraumatic wrist disorders.” Distal Interphalangeal Joint Bony Dimensions Related to Headless Compression Screw Sizes Pre and postoperative X-rays of a patient with end-stage arthritis of the distal interphalangeal joint of the finger treated with a fusion using a headless compression screw. • The distal phalanx shaft as measured on the lateral view was the narrowest determinant of fit. • W hen the dimensions of all the fixation devices were combined, screws were oversized relative to the bony anatomy in 66 percent of index fingers, 53 percent of middle fingers, 49 percent of ring fingers and 72 percent of little fingers. The mismatch was greater in women than men. •O nly one of the compression screw types (Acumed Acutrak Fusion) demonstrated a compatibility rate greater than 90 percent for the index and little fingers, respectively. Distal interphalangeal (DIP) joint arthrodesis using headless compression screws has gained popularity because of the screws’ ability to provide strong compression, allow for early mobilization and avoid the need for external hardware with its associated potential complications. Although high rates of union have been reported, these screw implants must be sized appropriately to the bony anatomy to minimize the risk of complications related to medullary reaming or incompatibility of screw size. • There was a positive correlation between greater patient height and good fit, a finding that suggests that mismatch is more likely to occur in shorter patients. Jefferson researchers headed by Kevin Lutksy, MD, Jonas Matzon, MD, and Pedro Beredjiklian, MD, conducted a study to determine the radiographic dimensions of the DIP joint and to compare these measurements with commonly used headless compression screws. Using standard posteroanterior and lateral radiographs of the hand, they measured the dimensions of the distal and middle phalanges in 60 index, middle, ring and little fingers and compared those measurements with the diameters and lengths of 16 commercially available screws commonly used for DIP joint arthrodesis. Percent compatibility and risk factors for incompatibility were determined. “Nevertheless, the small size of these bones, narrow soft tissue envelope and close proximity of the nailbed increase the possibility of screw-related complications including iatrogenic fracture (and potential loss of fixation), nail plate deformity, and discomfort with tip pinch related to hardware prominence,” they reported. “Therefore, ensuring that the chosen screw will fit the anatomy is of paramount importance.” The researchers noted that there are few reports in the literature of complications due to screw size mismatch, but that doesn’t mean the problem is insignificant. They said there may be some tolerance for a size mismatch. Among the findings, which were published in Journal of Hand Surgery (American Volume), were: • In general, commercially available screws were too large in diameter given the anatomic diameters of the DIP joint. 18 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research 1- 800 -JEFF-NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF-121 | physician referrals: 215-503-8888 19 MUSCULOSKELETAL ONCOLOGY 20 THE SPECIALISTS AT THE JEFFERSON MUSCULOSKELETAL ONCOLOGY CENTER ROUTINELY HANDLE SOME OF THE RAREST AND MOST DIFFICULT TYPES OF CANCER. SERVICES • Management of extremity bone sarcoma • Management of skeletal metastatic disease • Management of extremity soft tissue sarcoma • Management of spine lesions in conjunction with spine service • Pelvis sarcoma resection, bone and soft tissue • Subspecialty imaging review • Subspecialty pathology review • Complex joint reconstruction • Custom joint reconstruction • Acetabular revision joint procedures • • • Computer-navigated bone tumor resection Treatment of benign bone tumors Treatment of benign soft tissue tumors Tumors of the bone and soft tissue present not only a tremendous oncologic challenge, but they also require precise surgical attention in order to preserve limbs and limb function. The Center’s treatment team draws on the expertise of both Jefferson’s Department of Orthopaedic Surgery and the NCI-designated Sidney Kimmel Cancer Center at Thomas Jefferson University. Patients with a primary bone or soft tissue sarcoma or metastatic skeletal disease require a multi-modality approach to treatment, and the Center’s goal is to establish a treatment plan that can evolve with the patient’s needs. Common types of cancer frequently dealt with by the Center include osteosarcoma, chondrosarcoma, Ewing sarcoma, as well as all subtypes of soft tissue sarcoma. The Center, under the direction of John A. Abraham, MD, has a particular expertise in using computer-assisted surgical navigation for resection and reconstruction of malignant bone tumors, including those in difficult locations such as the spine and pelvis. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 21 MUSCULOSKELETAL ONCOLOGY Surgery Volume Source: Jefferson internal data Calendar YTD through September YTD 2014 YTD 2013 tumor out of the obturator ring of the pelvis without contaminating the surgical field with tumor. 326 307 TOTAL 2013 410 200 250 300350 400 The surgeons at the Musculokeletal Oncology Center also focus on research to improve the diagnosis and treatment of these rare and complex tumors. The surgeons’ contributions to the literature through the publications of original studies, review articles and case reports are helping to advance care beyond Jefferson. Dr. Abraham, in detailing his surgical approach for the two cases, said that the goal was “to achieve a negative margin resection while preserving limb function by resecting the obturator ring en bloc with the tumor.” A modified type III internal hemipelvectomy was used to excise the tumor and obturator ring in entirety as one large specimen, the team reported. Both patients remained disease-free for two years postoperatively. “Although the sample size is too small to draw conclusions, the cases described in this study offer a potential approach to tumors found in this location,” the researchers wrote. Here is some of their recently published research: Resection of Soft Tissue Tumors Extending Through the Obturator Ring 22 Mesh Reconstruction of the Inguinal Ligament with Bone Anchors Following Radical Oncologic Excision: A Case Series Soft tissue sarcomas account for approximately 1 percent of adult malignancies, and of those, only 5 percent are located in the pelvis. These tumors present a real challenge for clinicians. Pelvic soft tissue sarcomas are difficult to detect because the pelvis can be accommodating of large lesions, and often symptoms don’t become apparent until tumors have reached a considerable size. Compared with similar tumors found in the extremities, pelvis soft tissue sarcomas demonstrate a higher risk of recurrence, metastatic disease at presentation, extensive size, early local invasion and poorer prognosis. Surgical resection of pelvic tumors is extremely difficult because of proximity to critical organs, nerves and blood vessels. A subset of pelvic soft tissue sarcoma that is particularly problematic involves tumors that extend through the obturator ring. There is very little information available in the literature on how best to excise them. In a related study, Jefferson surgeons headed by Dr. Abraham reported on a case series involving six patients who underwent reconstructive surgery following radical excision of the obturator ring utilizing Dr. Abraham’s technique. The researchers reported in the journal Hernia on a technique they developed to reconstruct the inguinal ligament and abdominal wall using bioprosthetic mesh and bone anchors. A surgical team led by Dr. Abraham presented details on two cases in which a soft tissue sarcoma extended through the obturator ring. In one case, a 58-year-old woman presented with pain and swelling in the left leg. In the other case, a 60-year-old woman presented with painless swelling of the right thigh. In each case, a diagnostic workup revealed a malignant lesion extending through the obturator ring. It is difficult to resect tumors in this location because there is no good way to pull the T scans did not reveal any evidence of groin hernia in •C any of the patients. Six consecutive patients operated on using the described technique were followed to determine their level of pain and mobility six months postoperatively. The study found: • F our of six patients were able to mobilize without a cane, crutch, wheelchair or other assistive device. • F our of six patients were off narcotics and had no abdominal symptoms. The authors said their technique using bioprosthetic mesh and bone anchors provides the first description of an option for inguinal reconstruction following radical excision of the obturator ring. Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research Upper Extremity Considerations for Oncologic Surgery Primary bone and soft tissue tumors of the upper extremities are extremely rare, and they are particularly challenging clinically because treatment to eradicate the cancer must coincide with efforts to preserve function of a shoulder, arm or hand. It is imperative for clinicians to have a systematic approach to the diagnosis and treatment of bone and soft tissue tumors to maximize patient outcome. With advances in chemotherapy, radiotherapy, imaging and surgical reconstructive options, limb salvage surgery is estimated to be feasible in 95 percent of extremity bone or soft tissue sarcomas. In an article published in Orthopaedic Clinics of North America, John A. Abraham, MD, Director of the Musculoskeletal Oncology Center and Assistant Professor of Orthopaedic Surgery and Radiation Oncology, Sidney Kimmel Medical College at Thomas Jefferson University, and Justin C. Wong, MD, of the Department of Orthopaedic Surgery at Thomas Jefferson University, provided a detailed guide for clinicians on the diagnosis and management of upper extremity tumors. Among their diagnostic observations and recommendations: early 30 percent of soft tissue sarcomas occur in the •N upper extremity. Patients with a soft tissue tumor often present with a painless mass. A patient with a bone tumor may feel pain. • Elements of a patient’s history that should warrant a higher level of suspicion for a malignancy include change in the size of a mass, presence of night pain and, in some cases, symptoms such as fever, chills and night sweats. • Diagnostic imaging is a crucial component of the workup and should proceed in an organized fashion. Initial imaging often includes radiographs in orthogonal planes to localize and characterize the lesion. Ultrasound may help differentiate between a tumor and a cyst, and cross sectional imaging with CT or MRI can provide crucial information regarding size, tissue characteristics and anatomic relationship to other structures. • In aggressive appearing lesions and most soft tissue masses, a histologic specimen should be obtained for diagnosis. Soft tissue masses that are larger than 5 cm or deep to the investing fascia have an increased chance of being sarcoma and should be referred to an orthopaedic surgeon oncologist before obtaining biopsy. •C urrent grading and staging systems for musculoskeletal tumors are designed to guide treatment, provide diagnostic information for patients, and standardize research. A staging system for malignant bone tumors has been devised by the Musculoskeletal Tumor Society. A useful system for staging soft tissue sarcomas has been devised by the American Joint Committee on Cancer. Among their surgical recommendations: •T he primary goal of any surgical intervention for musculoskeletal tumors is local control of the cancer. • F amiliarity with nerve and vessel reconstruction, tendon transfer, soft tissue coverage and endoprosthetic reconstructions that maximize function is critical for the surgeon undertaking treatment of oncologic problems in the upper extremity. It is imperative for clinicians to have a systematic approach to the diagnosis and treatment of bone and soft tissue tumors to maximize patient outcome. With advances in chemotherapy, radiotherapy, imaging and surgical reconstructive options, limb salvage surgery is estimated to be feasible in 95 percent of extremity bone or soft tissue sarcomas. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 23 TRAUMA 24 IN ADDITION TO PROVIDING ROUND-THE-CLOCK STAFFING FOR TRAUMA, THE ORTHOPAEDIC TRAUMA TEAM FOCUSES ON RESEARCH THAT IS AIMED AT BOTH IMPROVED CARE AND PREVENTION OF ORTHOPAEDIC INJURIES SERVICES • • reatment of fractures, T both simple and complex, using both nonoperative and operative methods. Includes articular fractures and pelvic/ acetabular fractures ssessment and treatment A of problem fractures, those that have gone on to malunion or nonunion • Functional treatment of fragility fractures of the elderly • reatment of post T traumatic bone infections Patients treated at Jefferson for traumatic injury benefit from its designation as a Level 1 Trauma Center. Specialists in orthopaedic trauma are well versed in the care of complex, limb-threatening musculoskeletal injuries, as well as more routine fractures that can cause life-altering disability if not optimally treated. In addition to providing round-the-clock staffing for trauma, the orthopaedic trauma team focuses on research that is aimed at both improved care and prevention of orthopaedic injuries. One ongoing area of research interest is osteoporosis-related hip fractures — a problem that is likely to become even more pressing as the population ages. Here is a look at a recently published study. Association of Atypical Femur Fractures in Patients on Bisphosphonates with Varus Hip Geometry An estimated 10 million Americans have osteoporosis and over 1.5 million fractures a year are attributed to the disease. The incidence of osteoporosis is expected to double or triple in the next quarter of a century as the elderly population increases. The first commercially available bisphosphonate approved for the treatment of osteoporosis was introduced in the U.S. in 1995, and the drugs are now used by more than four million women in this country. While the osteoporosis drugs have been credited with lowering the rate of hip fractures among women, there is also evidence that the incidence of “atypical” femur fractures are increasing in women who take the drugs for a prolonged period of time. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 25 TRAUMA Surgery Volume Source: Jefferson internal data Calendar YTD through September YTD 2014 YTD 2013 The study found anatomical differences between patients who had a fracture and those who didn’t. Specifically: 119 TOTAL 2013 100 366 of the center of the femoral head (THC) distances were measured. 194 200 300 400 The cause of these fractures is unknown and likely multifactorial. Atypical characteristics of these fractures include fracture obliquity (transverse or short oblique), location in the femur (subtrochanteric or diaphyseal) and a very low energy mechanism (fall from ground level height or less.) James Krieg, MD, now Director of Orthopaedic Trauma at Jefferson, designed and directed a study to evaluate proximal femoral geometry in patients with primary osteoporosis on chronic bisphosphonate therapy. The study, published in Journal of Bone and Joint Surgery, was a multi-center retrospective case-control study conducted by Dr. Kreig before his appointment at Jefferson. It included 111 patients who had been treated for a complete or incomplete atypical femoral shaft fracture while on bisphosphonate therapy and a control group of 33 patients who had documented use of the drug for primary osteoarthritis but no history of fractures. The researchers reviewed radiographs to take measurements. The femoral neck-shaft angle (NSA) and the tip of the greater trochanter to the height • There was a statistically significant difference in the NSA of patients with atypical femur fractures compared to the controls (129.9 degrees on average compared to 133.8 degrees). • Fifty-three patients (47.7 percent) in the fracture group had an NSA lower than the lowest angle in the control group (128 degrees). “Patients on chronic bisphosphonates who presented with atypical fractures had more varus proximal femoral geometry than those without fractures,” the researchers concluded. “Although no causative effect can be determined, the presence of varus geometry may help better identify patients at risk for fractures after longterm bisphosphonate use.” The researchers noted that while more research is needed to confirm the study’s findings, it would be easy to use X-rays to identify patients who may be at particular risk for fractures while taking bisphosphonates and then counsel them on symptoms. “While this is likely only one piece of the picture, we feel our findings add a useful clinical marker that could help identify an ‘at risk’ subset of this population,” the researchers said. An estimated 10 million Americans have osteoporosis and over 1.5 million fractures a year are attributed to the disease. The incidence of osteoporosis is expected to double or triple in the next quarter of a century as the elderly population increases. 26 Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research This patient has an “atypical” femur fracture. It happened with very minor trauma. Once the fracture was treated surgically, she went on to healing and return of function. This patient had the radiographic and clinical changes that can precede an atypical fracture. By treating it prophylactically, surgeons were able to help her maintain function aftera brief recovery, without having to experience a fracture. 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 27 ONGOING CLINICAL TRIALS 28 Funded Clinical Trial Investigator(s) Prospective Post Market Clinical Follow-Up Study of the Zimmer Trabecular Metal Humeral Stem. Zimmer (04/05/2012–ongoing) Joseph A. Abboud, MD Retrospective, Post-Market, Clinical and Radiographic Follow-Up Study of the DePuy Delta Xtend Reverse Shoulder System. DePuy Synthes (9/24/2013–ongoing) Joseph A. Abboud, MD, Gerald R. Williams, Jr., MD A Phase II Randomized, Double-Blind, Placebo Controlled Study to Assess Safety, Tolerability and Effect on Tumor Size of MCS110 in Patients with Pigmented Villonodular Synovitis (PVNS). Novartis (10/1/2013–ongoing) John A. Abraham, MD Treatment of Plantar Fasciitis with Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study. Merz (4/05/2012–ongoing) Jamal Ahmad, MD A Prospective, Randomized Clinical Investigation of the Cervitech, Inc. Porous Coated Motion Artificial Disc for Stabilization of the Cervical Spine between C3-C4 and C7-T1. NuVasive (02/03/2005–ongoing) Todd J. Albert, MD, Alan S. Hilibrand, MD, Ashwini D. Sharan, MD A Multicenter Prospective Randomized Controlled Clinical Trial Comparing the Safety and Effectiveness of PRODISC-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)–Non randomized PRODISC-C continued access arm. Synthes Spine (04/28/2005–ongoing) D. Greg Anderson, MD, Todd J. Albert, MD, Alexander R. Vaccaro, MD, PhD A Prospective, Randomized, Double Blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients with Chronic Axial Low Back Pain. Relievant (04/2012–ongoing) D. Greg Anderson, MD, Kris E. Radcliff, MD Post-Market Clinical Follow-Up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used with the Continuum Acetabular Shell. Zimmer (10/1/2013–ongoing) William V. Arnold, MD, PhD, Javad Parvizi, MD Prospective Post-Market Clinical Follow-Up of the Zimmer Trabecular Metal Reverse Shoulder System. Zimmer (08/2011–ongoing) Luke S. Austin, MD, Matthew D. Pepe, MD, Bradford S. Tucker, MD Prospective Clinical Evaluation Treating Subchondral Bone Marrow Lesions with Subchondroplasty for Pain Relief. Knee Creations LLC (3/15/2012–ongoing) Steven B. Cohen, MD Trabecular Metal Femoral Hip Stem Used within the Zimmer Hip Registry. Zimmer (02/09/2012–ongoing) Carl Deirmengian, MD Prospective Post-Market Clinical Follow-Up of the Zimmer Trabecular Metal Reverse Shoulder System. Zimmer (08/23/2011–ongoing) Charles L. Getz, MD, Matthew L. Ramsey, MD Ascension Radial Head. Integra Life Sciences (09/2012–ongoing) Charles L. Getz, MD, Matthew L. Ramsey, MD, Joseph A. Abboud, MD Muticenter Trial of the Sidus Stem Free Shoulder Arthroplasty System. Zimmer (7/18/2013–ongoing) Charles L. Getz, MD, Matthew L. Ramsey, MD, Joseph A. Abboud, MD Post-Market Study of the Stryker Orthopaedics Triathlon TS Total Knee System. Stryker Orthopaedics (4/1/2012–ongoing) Fabio R. Orozco, MD, Alvin C. Ong, MD Persona Outcomes Knee Study (POLAR). Zimmer (3/1/2013–ongoing) Matthew S. Austin, MD Skelkast Surpass Post-Approval Active Surveillance. Skelkast (10/2012–ongoing) Peter F. Sharkey, MD, Rob Good, MD Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research Funded Clinical Trial Investigator(s) Retrieval of Discarded Surgical Tissue. National Disease Registry Institute (1/12/2004–6/30/2013) Javad Parvizi, MD, Peter F. Sharkey, MD, James J. Purtill, MD, William J. Hozack, MD, Richard H. Rothman, MD, PhD Multicenter Trial of the Continuum Ceramic Bearing System in Total Hip Arthroplasty. Zimmer (08/05/2010–ongoing) Javad Parvizi, MD, William J. Hozack, MD, Matthew S. Austin, MD American Joint Replacement Registry (12/23/2010–ongoing) Javad Parvizi, MD A Phase II Study to Determine the Efficacy and Safety of Allogeneic Human Chrondrocytes Expressing TGF-ß1 in Patients with Grade 3 Chronic Degenerative Joint Disease of the Knee (09/01/2011–ongoing) Javad Parvizi, MD, Marc I. Harwood, MD, Peter C. Vitanzo, Jr., MD Evaluation of In-vivo Wear of Ceramic Femoral Head Against Highly Cross-Linked Polyethylene: A Comparative Study. Ceramtec (11/2011–ongoing) Javad Parvizi, MD A Post-Market, Prospective, Single Center, Randomized, Pilot-Phase Investigation of the Effects of PlasmaBlade™ Dissection and Coagulation on Soft Tissue Inflammation Parameters Following Total Knee Arthroplasty. Medtronic (5/17/2013–ongoing) Javad Parvizi, MD Evaluation of the Clinical Utility of the Cobas® MRSA/SA Test for Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus from Nasal Swabs. Roche Molecular Systems (7/1/2013–ongoing) Javad Parvizi, MD A Prospective, Randomized, Controlled, Multicenter, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment Injectable Bone Graft Compared to Autologous Bone Graft as Bone Regeneration Device in Hindfoot Fusions. BioMimetic (4/7/2011–ongoing) Steven M. Raikin, MD Characterization of Bone Marrow Lesions in Retrieved Tibial Plateaus. Knee Creations LLC (8/3/2011–ongoing) Peter F. Sharkey, MD Efficacy of Riluzole in Patients with Cervical Spondylotic Myelopathy Undergoing Surgical Treatment, A Randomized, Double-Blind Placebo-Controlled, Multicenter Study. AOSpine North America (02/16/2012–ongoing) Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, Alan S. Hilibrand, MD, D. Greg Anderson, MD, Jeffrey A. Rihn, MD, Kris E. Radcliff, MD Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC). Quality of Life and Cost-Effectiveness Outcomes. AOSpine North America (02/14/2008–ongoing) Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, Alan S. Hilibrand, MD, D. Greg Anderson, MD, Jeffrey A. Rihn, MD, Kris E. Radcliff, MD An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation Investigational Plan. Cerapedics (06/07/2007–ongoing) Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, James S. Harrop, MD, Ashwini D. Sharan, MD, Srinivas Prasad, MD, Jack Jallo, MD, PhD, FACS Addendum to Investigational Plan 1003 Version 5.3 IDE Protocol G050178: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation. Cerapedics (03/11/2010–ongoing) Alexander R. Vaccaro, MD, PhD, Todd J. Albert, MD, James S. Harrop, MD 1- 800 -JEFF - NOW | Jefferson.edu/Orthopedic | transfers: 1- 800 - JEFF -121 | physician referrals: 215-503-8888 29 JG 14-2305 ONGOING CLINICAL TRIALS 30 Funded Clinical Trial Investigator(s) Prospective, Multicenter Single Arm Study to Assess Clinical Outcomes in Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement. Tornier/LifeCell (02/18/2010–ongoing) Gerald R. Williams, MD Bacterial colonization with and without iodophor-impregnated adhesive drapes in hip surgery: a prospective, randomized, multicenter trial. 3M Corporation (06/2014–present) Javad Parvizi, MD, Antonia Chen, MD Retrospective and Prospective Data Collection Study of the TITAN Modular Total Shoulder System (TSS). Integra (08/2014–present) Surena Namdari, MD, Matthew Ramsey, MD, Joseph Abboud, MD, Mark Lazarus, MD, Gerald Williams, MD, Charles Getz, MD A Pivotal, Multicenter, Double-Blind Study of the Safety and Effectiveness of Synvisc-One® (hylan G-F 20) in Patients with Mild to Moderate Primary Osteoarthritis of the Hip. Genzyme (06/2014–present) Javad Parvizi, MD, Barry Kenneally, MD, Mitch Freedman, MD, Alvin Ong, MD, Fabio Orozco, MD Prospective Post Market Clinical Follow-Up Study of the Zimmer® Trabecular Metal™ Total Ankle System. Zimmer (08/2014–present) Steven Raikin, MD, David Pedowitz, MD The Influence of a Natural Anti-Inflammatory Product on Levels of Inflammatory Markers in Cases of Osteoarthritis of the Knee. PRN Neutriceuticals (03/2013–present) Peter Sharkey, MD, Javad Parvizi, MD A Multi-Centre 2x2 Factorial Randomized Trial Comparing Sliding Hip Screws versus Cancellous Screws AND Vitamin D versus Placebo on Patient Important Outcomes and Quality of Life in the Treatment of Young Adult (18-60) Femoral Neck Fractures. McMaster University (08/2014–present). James Krieg, MD, Asif Ilyas, MD, Gregory Deirmegian, MD, Sommer Hammoud, MD, John A. Abraham, MD, Jamal Ahmad, MD Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements. McMaster University (02/2014–present) John A. Abraham, MD, Barry Kenneally, MD Multi-Institutional Trial using Qualitative CT Scan for Determining Pathologic Fracture Risk in Skeletal Malignancy. Musculoskeletal Tumor Society (8/2014–ongoing) John A. Abraham, MD, Barry Kennealy, MD Basal Joint Arthroplasty Pain Management – Prospective Comparative Study. Pacira (08/2013–present) Fred Liss, MD, Asif Ilyas, MD, Charles Leinberry, MD, Pedro Beredjiklian, MD Triathlon Tritanium Knee Outcomes Study. Stryker (04/2014–present) Fabio Orozco, MD, Alvin Ong, MD, Zachary Post, MD Post Market Study of the Stryker Orthopaedics Triathlon PKR Knee System. Stryker (11/2013–Present) Fabio Orozco, MD, Alvin Ong, MD, Zachary Post, MD Comparing Pain Relief between Exparel® Injection Versus On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA). Sharpe-Strumia Research Foundation (07/01/2013–ongoing) Eric B. Smith, MD, Jess H. Lonner, MD, Peter F. Sharkey, MD Outcomes of Patients following Primary Total Knee Replacement. Stelkast (6/7/2013–ongoing) Peter F. Sharkey, MD Thomas Jefferson University Hospitals | Orthopaedic Outcomes and Research Thomas Jefferson University Hospitals Department of Orthopaedic Surgery Philadelphia, PA 19107 Patient Appointments: 1-800-JEFF-NOW Patient Transfers: 1-800-JEFF-121 Physician Referrals: 215-503-8888 Jefferson.edu/Orthopedic The Art of Orthopaedics