The Furlong® Hemiarthroplasty System
Transcription
The Furlong® Hemiarthroplasty System
D sp esi He ecifi gne d mi art cally hro fo pla r sty The Furlong® Hemiarthroplasty System Contents System Benefits 2 Company Overview 2 Furlong® Cemented Hemiarthroplasty Design Attributes 3 Clinical Evidence 3 Implant Range 5 Operative Technique 7 Instrumentation 10 Furlong® Hydroxyapatite Ceramic Coated Hemiarthroplasty Design Attributes 13 Clinical Evidence 13 Implant Range 15 Operative Technique 17 Instrumentation 21 System Benefits The Furlong® Arthroplasty System • Cemented or H-A.C. Coated stem options and bi-polar or physiological head options provide clinical flexibility to match surgeon preference • The fully modular system allows the surgeon to select the implants which best meet the patients clinical needs • Versatility of the system allows for easy conversion to a total hip construct should this be required intra or post operatively • Easy to use effective instrumentation designed to enhance clinical outcome • Clinically proven1,2,3 Company Overview • JRI Limited, established in 1970 by Mr Ronald Furlong FRCS • Developers of the world’s first H-A.C. coated hip replacement Prosthesis – first Furlong H-A.C. total hip replacement implanted 9 September 1985 • Market leading peer reviewed clinical results • Dedicated orthopaedic research, development and manufacturing 2 Furlong® Cemented Hemiarthroplasty Design Attributes The Furlong® cemented hemiarthroplasty stem is a Müller type femoral stem that has been devised to incorporate the design features and clinical success of the Furlong cemented primary modular stem which has received an ODEP rating of 10 C Available in 5 stem sizes, designed to ensure optimal match to patient’s anatomy Cost effective system compared to a total hip replacement Collarless, double tapered, polished high nitrogen stainless steel stem, designed to facilitate accurate placement of the prosthesis in the cement mantle. Clinical Evidence 72 Implants had been inserted into 71 different patients by 35 different Surgeons of all grades. No dislocations in any of the 72 patients who had bi-polar hips inserted during the study period1 Comparable with results of total hip replacement (THR) but without the risk of dislocation1 Results are significantly better than would be expected with conventional Hemiarthroplasty in this group of patients1 Eleven of the sixteen able to walk 1 mile before fracture were able to do so at review. Mean follow up 32 months.1 3 A more flexible choice for you... ...a better outcome for Mary 4 Furlong® Cemented Hemiarthroplasty The JRI Bipolar head is pre assembled and available in 1mm increments. It has been designed specifically to minimize the risk of the prosthesis assuming a varus position. The JRI Physiological Head is manufactured from proven High Nitrogen Stainless Steel. This increases biocompatibility and provides greater fatigue strength and corrosion resistance over conventional medical grade stainless steel. 12-14 Taper allows for easy conversion to a total hip at a later date should this be required The highly polished surface finish allows for controlled subsidence and self locking in the cement mantle. Based on the proven 1979 design of the Furlong® Straight Stem. The high nitrogen stainless steel stem is double tapered, collarless and polished for longevity of cement fixation. Longer stem available to cater for most surgical requirements. 127º The 127º neck angle increases stability and reduces the risk of dislocation. 5 DESCRIPTION Femoral Stems (Standard Stem) Extra Extra Small Stem Extra Small Stem Small Stem Medium Stem Large Stem Femoral Stems (Long Stem) Small Stem Medium Stem Large Stem Bipolar Heads 40mm O/D 41mm O/D 42mm O/D 43mm O/D 44mm O/D 45mm O/D 46mm O/D 47mm O/D 48mm O/D 49mm O/D 50mm O/D 51mm O/D 52mm O/D 53mm O/D 54mm O/D 56mm O/D 58mm O/D Physiological Heads 39mm O/D 40mm O/D 41mm O/D 42mm O/D 43mm O/D 44mm O/D 45mm O/D 46mm O/D 47mm O/D 48mm O/D 49mm O/D 50mm O/D 51mm O/D 52mm O/D 53mm O/D 54mm O/D 56mm O/D 58mm O/D PRODUCT NO. 95.08.00 95.10.00 95.12.00 95.15.00 95.18.00 95.12.25 95.15.25 95.18.25 94.40.01 94.41.01 94.42.01 94.43.01 94.44.01 94.45.01 94.46.01 94.47.01 94.48.01 94.49.01 94.50.01 94.51.01 94.52.01 94.53.01 94.54.01 94.56.01 94.58.01 93.39.01 93.40.01 93.41.01 93.42.01 93.43.01 93.44.01 93.45.01 93.46.01 93.47.01 93.48.01 93.49.01 93.50.01 93.51.01 93.52.01 93.53.01 93.54.01 93.56.01 93.58.01 6 Furlong® Cemented Hemiarthroplasty 7 1 2 Correct positioning of the patient, on the operating table, is very important and the hip joint is exposed using a preferred surgical approach for hemiarthroplasty. The femoral neck is cut 1-2cm above the lesser trochanter. (This cut can be determined by where the fracture has occurred). A trial stem can be used, if required, to help identify where the neck cut should be and a line made using a diathermy probe or skin marker. 3 4 The saw cut should be perpendicular to the neck and the position of the tibia should be vertical while the cut is made. The femoral head is removed using the corkscrew. A light tap may help engagement and purchase into the femoral head. 5 6 The femoral head size can then be estimated using the femoral head template guide. Sizing is confirmed using the trial heads and introducer. The Labrum is best left intact but, if necessary, can be sectioned at this point to allow the correct size head to be selected. Operative Technique 7 8 The proximal femur is opened using the box chisel which is positioned laterally and posteriorly so that entry is in line with the femoral intramedullary canal. The smallest (4-8mm tapered) intramedullary reamer, which has a sharp tip, is mounted on the T-Handle, and used to expose the femoral canal. Care should be taken with this first reamer and if bone quality is poor then the 8mm intramedullary reamer should be used first, as it has a more rounded tip. Further straight reamers are used increasing in 1mm size increments until an acceptable reaming has been achieved. 9 10 The smallest rasp (extra, extra small) is used to prepare the proximal femur. The large tommy bar should be used to control version. If the fit of this first rasp is unsatisfactory then repeat the procedure increasing rasp size accordingly. Care should be taken to lateralise the rasps as they are inserted. At this point, if required, the appropriate trial stem can be carefully inserted using the stem impactor. 11 12 The chosen trial head is screwed onto the trial prosthesis and a reduction attempted. If the reduction is not possible or is regarded as too tight, remove the trial prosthesis. The neck should be resected further to permit deeper seating of the stem. Seat the rasp again and repeat the trialing process until the reduction is stable. The trial stem can be removed with the use of the trial stem extractor. Care must be taken to tap out of the femur in a neutral position to prevent possible damage to the femur. 8 Operative Technique Continued 9 13 14 At this point a suitable size of cement restrictor or plug is chosen, depending on the size of the final intramedullary reamer used and screwed onto the introducer. The depth of insertion is determined by placing the cement plug introducer alongside the trial/prosthesis. The plug is aligned 1–2cm beyond the distal tip of the trial/prosthesis and a measurement taken from the markings on the introducer handle. The lateral shoulder of the trial/prosthesis is a good reference point. (Ref Page 10 Chart A) The plug is then inserted into the femoral canal at a depth of 1–2cm beyond the distal tip of the prosthesis. To remove the introducer handle turn anti-clockwise to unscrew from the plug. Do not remove the introducer handle until the plug is seated correctly at the premeasured depth. 15 16 The preferred cementing technique is now used. Modern techniques recommend the use of a cement plug, lavage, drying of the femoral canal and retrograde filling with a cement gun. Making sure the tibia is vertical, the definitive femoral stem should be inserted in neutral alignment, to ensure a continuous circumferential cement mantle, using the stem impactor and inserted to the depth determined by the trial prosthesis. The depth of the stem should be determined by the height of the centre of rotation of the femoral head on the contralateral side. If the same size rasp, trial and definitive stem are used then a cement mantle of approx. 1-2mm will be obtained. Should a thicker cement mantle be required, then a smaller size of prosthesis than the size of the last rasp used, should be selected. 17 18 Before fitting the Bipolar or mono-polar, physiological femoral head ensure that the cement is fully cured and set. The implant head (either bi-polar or mono-polar, physiological) is fitted onto the stem and impacted using the femoral head impactor. A light tap is required to engage the taper. Operative Technique 19 Finally the joint is reduced, and the wound is closed. Furlong® Cemented Instrumentation Chart A Intramedullary Rasp Reamer Size (mm) Implant Size Cement Plug (mm) Extra Extra Small or 10 9 10 Extra Small or 11 Small 12.5 14 Medium or 15 16 Large 17.5 or 20 12 1 DESCRIPTION 1 Cement Plug 2 Size AA 10.0mm Diameter Size OA 12.5mm Diameter Size OB 15.0mm Diameter Size OC 17.5mm Diameter Size OD 20.0mm Diameter Cement Plug Introducer 2 PRODUCT NO. 13.00.03 13.00.04 13.00.05 13.00.06 13.00.07 13.00.01 10 Furlong® Cemented Instrumentation 1 4 2 5 3 6 DESCRIPTION PRODUCT NO. 1 Trial Head Introducer 10.00.44 2 3 4 5 6 Head Impactor Trial Stem Extractor Box Chisel Stem Impactor Femoral Head Extractor 10.00.47 10.00.08 50.99.45 50.99.34 10.00.21 13 10 7 12 8 11 9 7 8 9 10 11 12 13 11 Intramedullary Reamers 4-8mm 8mm 9mm 14.48.61 14.61.08 14.61.09 10mm 14.61.10 11mm 14.61.11 12mm 14.61.12 13mm 14.61.13 14mm 16mm Small Tommy Bar Large Tommy Bar Hudson Adaptor Jacobs Adaptor T Handle Femoral Head Gauge 14.61.14 14.61.16 10.08.28 10.25.28 10.00.26 10.00.27 10.00.50 64.00.18 15 14 14 Trial Stems (Threaded Spigot) Extra Extra Small 96.08.08 Extra Small 96.08.10 Small Medium Large Small Trial Long Stem Medium Trial Long Stem Large Trial Long Stem 15 Rasps Extra Extra Small Extra Small Small Medium Large 96.08.12 96.08.15 96.08.18 96.25.12 96.25.15 96.25.18 50.00.14 50.00.15 50.00.16 50.00.17 50.00.18 16 DESCRIPTION 16 17 PRODUCT NO. DESCRIPTION 17 Bipolar Trial Heads (Black) 40mm 41mm 42mm 43mm 44mm 45mm 46mm 47mm 48mm 49mm 50mm 51mm 52mm 53mm 54mm 56mm 58mm Available as a revision option 64.40.94 64.41.94 64.42.94 64.43.94 64.44.94 64.45.94 64.46.94 64.47.94 64.48.94 64.49.94 64.50.94 64.51.94 64.52.94 64.53.94 64.54.94 64.56.94 64.58.94 PRODUCT NO. Physiological Trial Heads (White) 39mm 64.39.10 40mm 64.40.10 41mm 64.41.10 42mm 64.42.10 43mm 64.43.10 44mm 64.44.10 45mm 64.45.10 46mm 64.46.10 47mm 64.47.10 48mm 64.48.10 49mm 64.49.10 50mm 64.50.10 51mm 64.51.10 52mm 64.52.10 53mm 64.53.10 54mm 64.54.10 56mm 64.56.10 58mm 64.58.10 12 Furlong® H-A.C. Hemiarthroplasty Design Attributes Supravit® H-A.C. coating and stem geometry are identical to the Furlong® H-A.C. hip replacement, which has an ODEP rating of 10 A Very impressive clinical results have shown that Supravit makes the Furlong® H-A.C. Total Hip Replacement, possibly the most successful uncemented hip stem4-12 Can be used on patients with osteoporotic bone13 Cost effective compared to Total Hip Replacement Clinical Evidence We conclude that Hemiarthroplasty with the Hydroxyapatite coated Bipolar Furlong® prosthesis for displaced intracapsular fracture of the neck of the femur gives good mid term results in elderly patients for return to mobility, use of mobility aids and freedom from pain2 Modularity of the head allows later conversion to total hip arthroplasty without revision of the stem2 Use of the Hydroxyapatite–coated stem eliminates the need for cement and its attendant risks to the cardio respiratory system in the elderly and often frail population2 The results of our study indicate that hip Hemiarthroplasty using the Furlong® H-A.C. coated implant is associated with good functional recovery in terms of mobility and reliance on walking aids2 The mean Clinical Rating Score was 70 ( Harris Hip Score 80.6 ). 86% had no pain and 90% were satisfied. This prosthesis functions well in the active elderly patient with a displaced intracapsular proximal femoral fracture3 13 A more flexible choice for you... ...a better outcome for Barbara 14 Furlong® H-A.C. Hemiarthroplasty The JRI Bipolar head is pre assembled and available in 1mm increments. It has been designed specifically to minimize the risk of the prosthesis assuming a varus position. The JRI Physiological Head is manufactured from proven High Nitrogen Stainless Steel. This increases biocompatibility and provides greater fatigue strength and corrosion resistance over conventional medical grade stainless steel. 12-14 Taper allows for an easy conversion to a total hip replacement at a later date, should this be required 127º The 127º neck angle increases stability and reduces the risk of dislocation. Proximal stem geometry aids primary fixation of the implant The collar of the implant helps neutral alignment of the prosthesis. 15 Proven stem design of the Furlong® H-A.C. Total Hip Replacement Fully coated with Supravit® hydroxy-apatite ensuring even distribution of forces transmitted through the prosthesis to the host bone. DESCRIPTION PRODUCT NO. H-A.C. Femoral Stems 9mm 97.09.00 10mm 97.10.00 11mm 97.11.00 12mm 97.12.00 13mm 97.13.00 14mm 97.14.00 16mm 97.16.00 Bipolar Heads 40mm O/D 94.40.01 41mm O/D 94.41.01 42mm O/D 94.42.01 43mm O/D 94.43.01 44mm O/D 94.44.01 45mm O/D 94.45.01 46mm O/D 94.46.01 47mm O/D 94.47.01 48mm O/D 94.48.01 49mm O/D 94.49.01 50mm O/D 94.50.01 51mm O/D 94.51.01 52mm O/D 94.52.01 53mm O/D 94.53.01 54mm O/D 94.54.01 56mm O/D 94.56.01 58mm O/D 94.58.01 Physiological Heads 39mm O/D 93.39.01 40mm O/D 93.40.01 41mm O/D 93.41.01 42mm O/D 93.42.01 43mm O/D 93.43.01 44mm O/D 93.44.01 45mm O/D 93.45.01 46mm O/D 93.46.01 47mm O/D 93.47.01 48mm O/D 93.48.01 49mm O/D 93.49.01 50mm O/D 93.50.01 51mm O/D 93.51.01 52mm O/D 93.52.01 53mm O/D 93.53.01 54mm O/D 93.54.01 56mm O/D 93.56.01 58mm O/D 93.58.01 16 Furlong® H-A.C. Hemiarthroplasty 17 1 2 Correct positioning of the patient, on the operating table, is very important and the hip joint is exposed using a preferred surgical approach for hemiarthroplasty. The femoral neck is resected. (This cut can be determined by where the fracture has occurred). A trial stem, rasp or template can be used, if required, to help identify where the neck cut should be and a line made using a diathermy probe or skin marker. 3 4 The femoral head is removed using the corkscrew. A light tap may help engagement and purchase into the femoral head. The size of the femoral head can then be estimated using the femoral head template guide. 5 6 The actual implant head to be used (either bi-polar or mono-polar, physiological) is determined using the trial heads and introducer. The Labrum is best left intact but, if necessary, can be sectioned at this point to allow the correct size head to be selected. The proximal femur is opened using the box chisel which is positioned laterally and posteriorly so that entry is in line with the femoral intramedullary canal. Operative Technique 7 8 The smallest (4-8mm tapered) intramedullary reamer, which has a sharp tip, is mounted on the T-Handle, and used to open up the femoral canal. Care should be taken with this first reamer and if the bone quality is poor then the 8mm intramedullary reamer should be used first in its place, as it has a more rounded tip. Next the 9mm intramedullary reamer is used. 9 10 The smallest rasp (Size 9) is used first to prepare the proximal femur. The small tommy bar is used to control version. If the fit of this first rasp is unstable then the next size of intramedullary reamer is used followed by the corresponding size of rasp. This ream / rasp technique is continued until the fit of the rasp is stable. 11 12 With the correct rasp in place remove the rasp handle and if required, trim the neck using the calcar cutter fitted onto the T-handle. With the rasp still in place, the fin cutter is gently tapped home into the groove in the rasp with the teeth facing the greater trochanter. 18 Furlong® H-A.C. Hemiarthroplasty 13 At this point, if required, the appropriate trial stem prosthesis can be carefully inserted using the stem impactor. 15 The chosen trial head is screwed onto the trial prosthesis and a reduction attempted. If the reduction is not possible or is regarded as too tight, the trial prosthesis is removed and the neck resected further to permit deeper seating of the stem. The rasp is seated again and the trialing process repeated until the reduction is satisfactory. 16 The trial stem can be removed with the use of the trial stem extractor. Care must be taken to tap the trial out of the femur in a neutral position to prevent possible damage to the femur. The definitive femoral stem should be inserted using the stem impactor and tapped home to the depth determined by the trial prosthesis. 17 18 Seating of the collar on the calcar is preferred but not essential. 19 14 The implant head (either bi-polar or mono-polar, physiological) is fitted onto the stem and impacted using the nylon femoral head impactor. A light tap is required to engage the taper. Operative Technique Continued 19 Finally the joint is reduced and the wound is closed. 20 Furlong® H-A.C. Instrumentation 1 4 2 5 3 6 DESCRIPTION PRODUCT NO. 1 Trial Head Introducer 10.00.44 2 3 4 5 6 Head Impactor Trial Stem Extractor Box Chisel Stem Impactor Femoral Head Extractor 10.00.47 10.00.08 50.99.45 50.99.34 10.00.21 13 7 8 11 12 9 10 7 8 9 10 11 12 13 21 Intramedullary Reamers 4-8mm 9mm 14.48.61 14.61.09 10mm 14.61.10 11mm 14.61.11 12mm 14.61.12 13mm 14.61.13 14mm 16mm Small Tommy Bar Small Tommy Bar Fin Cutter Calcar Cutter T Handle Femoral Head Gauge 14.61.14 14.61.16 10.08.28 10.08.28 90.99.02 90.00.23 10.00.50 64.00.18 14 16 15 14 Trial Stems 9mm 98.08.09 10mm 98.08.10 11mm 12mm 13mm 14mm 16mm 15 Rasp Handle 16 Rasps 9mm 10mm 11mm 12mm 13mm 14mm 16mm 98.08.11 98.08.12 98.08.13 98.08.14 98.08.16 200.02.99 91.11.09 91.11.10 91.11.11 91.11.12 91.11.13 91.11.14 91.11.16 17 DESCRIPTION 17 18 PRODUCT NO. 18 Bipolar Trial Heads (Black) 40mm 41mm 42mm 43mm 44mm 45mm 46mm 47mm 48mm 49mm 50mm 51mm 52mm 53mm 54mm 56mm 58mm DESCRIPTION 64.40.94 64.41.94 64.42.94 64.43.94 64.44.94 64.45.94 64.46.94 64.47.94 64.48.94 64.49.94 64.50.94 64.51.94 64.52.94 64.53.94 64.54.94 64.56.94 64.58.94 PRODUCT NO. Physiological Trial Heads (White) 39mm 64.39.10 40mm 64.40.10 41mm 64.41.10 42mm 64.42.10 43mm 64.43.10 44mm 64.44.10 45mm 64.45.10 46mm 64.46.10 47mm 64.47.10 48mm 64.48.10 49mm 64.49.10 50mm 64.50.10 51mm 64.51.10 52mm 64.52.10 53mm 64.53.10 54mm 64.54.10 56mm 64.56.10 58mm 64.58.10 22 JRI Services/Education • Research Funding • In service support • Nurse Training • Consignment stock checks: • Implants • Factory Tours • Instruments • Furlong Hip Course • PACS Digital X-Ray templates References: 1. S Dixon et al. Cemented Bipolar Hemiarthoplasty for Displaced Intracapsular Fracture in the Mobile Active Elderly Patient. Int. J Care Injured 2004; 35:152-156. 2. P Chandran et al. Mid Term Results of Furlong LOL Uncemented Hip Hemiarthroplasty for Fractures of the Femoral Neck. Acta Orthop. Belg., 2006; 72:426-433. 3. R Rees et al. The JRI Bipolar Hemiarthroplasty for the Active Patient With a Displaced Intracapsulat Proximal Femoral Fracture. BOA 2001. 4. Survivorship of 38 cases in under 50 year olds. N.N. Shah et al J Bone Joint Surg [Br] 2009; 91-B:865-9 5. Survivorship of 331 consecutive cases. J.A.N Shepperd et al J Bone Joint Surg [Br] 2008; 90-B:27-30 6. Survivorship of 134 consecutive cases. A.A. Shetty et al J Bone Joint Surg [Br] 2005; 87-B:1050-4 7. Survivorship in 2212 cases. J.M. Buchanan, Sunderland Royal Hospital Data presented at BOA, Manchester, 26 - 28 September 2007. 8. Sources: Fisher J, University of Leeds (UK); Pandorf T, CeramTecAG (Germany), 2006 9. Buchanan J.M. A nineteen-year review of hydroxyapatite ceramic coated hip implants: a clinical and histological evaluation. BOA, 2007; Manchester 26-28th September 2007. 10. Raman R, David D, Eswaramoorthy V, Tiru M, Angus P; Long term results of 586 cementless primary total hip arthroplasties using H-A.C. coated endoprosthesis: BOA ; Manchester 26-28th September 2007. 11. Escriba I, Sancho R, Crusi X, Valera M; Hemispherical hydroxyapatite-coated cups for acetabular revision in severe bone defects: 3 to 7 year results. EFORT, Helsinki, Finland, June 4 -10th 2003. 12. Data on file. 13. Data on file – published at EFORT AOS 2008. Wholly owned by the Furlong Research Charitable Foundation who independently fund orthopaedic research Joint Replacement Instrumentation Limited 18 Churchill Way, 35A Business Park, Chapeltown, Sheffield S35 2PY T: 0114 345 0000 F: 0114 345 0004 W: www.jri-ltd.co.uk 0473 CCG VS01/07/2010