Oxford Partial Knee. A Definitive Implant. Tibial Component. Anatomical shape for optimal bone coverage



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Transcription:

Oxford Partial Knee

Oxford Partial Knee A Definitive Implant With over 35 years clinical experience, the Oxford Partial Knee is the most widely used 1 and proven 2 partial knee system in the world. Tibial Component Anatomical shape for optimal bone coverage

Femoral Component Conforming, spherical design minimizes contact stress throughout entire range of motion 1 Curved inner geometry for minimal bone removal 1 A multi-center study 6 found that Oxford PKR patients were 1.8 times more likely to report that their knee felt normal and 2.7 times more satisfied with their ability to perform activities of daily living compared to TKA patients A survey 7 showed that Oxford partial knee patients are happier with their knee replacements than total knee patients A multi-centre study demonstrated decreased morbidity and complications of PKA compared to TKA 8 * Proven, 2 safe and reproducible technique 9 Better functionality 10 and more natural motion 12 compared to TKA Mobile Meniscal Bearing Only true mobile meniscal bearing knee system approved for use in the U.S. Mobile bearing designed to remain fully congruent with femoral component throughout entire range of motion 3 Best-in-class continuous education program Survivorship Proven wear resistance with ArCom Direct Compression Molded polyethylene 4,5 94 % 91 % at 15 years 2,13,14 at 20 years 2

Oxford Partial Knee Microplasty Partial Knee Instrumentation The Oxford Partial Knee System continues to advance partial knee arthroplasty with Microplasty Instrumentation. This instrumentation platform provides surgeons with innovative tools to help with ease of use, precision, efficiency and reproducibility 9 for each patient: Proprietary tibial resection guide that uses patients normal MCL tension to determine level of tibial resection The soft-tissue referencing Microplasty instrumentation references the posterior femoral condyle to set the amount of tibial resection. Spherical mill and spigots provide a simplified approach to balancing the flexion and extension gaps Size specific femoral instrumentation for precise 1 mm incremental bone removal The Femoral Drill Guide linked to the IM rod provides for accurate and reproducible alignment 9 The Anti-Impingement guide is designed to help surgeons minimize anterior bearing impingement with precise guided instrumentation

Oxford Partial Knee and Today s Fixed Bearing Partial Knee Replacements The Oxford Partial Knee has demonstrated 91% survivorship at 20 years. 2 Because of its congruent, forgiving design, the Oxford has demonstrated ultra low polyethylene wear in multiple retrieval studies 14,15 No significant correlation exists between preoperative evidence of PFJ (Patellofemoral Joint) disease** and poor outcomes with Oxford Partial Knee 16,17 One published study found the Oxford Partial Knee restored joint kinematics better than one fixed bearing partial knee replacement design, reporting the following: Larger and incremental increase in tibial internal rotation 18 More consistent AP translation of the medial femoral condyle 18 More consistent AP translation of contact point 18 ** Patellofemoral joint damage must be limited to (or greater on) the medial facets

Oxford Partial Knee Clinically Proven Sources Type (NJR, Publications etc.) N (All patients are Oxford partial knees unless stated otherwise) Survivorship Berend, M. E. Mobile Bearing Partial Knee Arthroplasty. 19 Presentation 2,029 knees 98.0% at a mean of 78 months Bergeson, AG et al. Medial mobile bearing unicompartmental knee arthroplasty early survivorship and analysis of failures in 1000 consecutive cases. Journal of Publication 1,000 knees Arthroplasty. 2013 20 95.2% at a mean of 44 months Carr, A. et al. Medial Unicompartmental Arthroplasty: A Survival Study of the Oxford Meniscal Knee. Clinical Orthopedics and Related Research. Publication 121 295:205 213. 1993. 21 99.1% at 9 years (cumulative survivorship) Faour-Martin, O. et al. Oxford phase 3 unicondylar knee arthroplasty through a minimally invasive approach: long term results. International Publication 511 knees Orthopaedics, 2013. 22 94.7% at 10 years Gondusky, Joseph S., et al. Day of Surgery Discharge after Unicompartmental Knee Arthroplasty: An Effective Perioperative Pathway. The Journal of arthroplasty (2013). 23 Publication 160 knees (73.1% of implants were Oxford) 98.75% at a mean of 24 months Jones, L et al. 10 year survivorship of the medial oxford unicompartmental knee arthroplasty. A 1000 patient non-designer series- the effect of surgical grade Publication 1,085 knees and supervision. Osteoarthritis and Cartilage. 2012;20:S290-S291 24 91% at 10 years Keys GW, Ul-Abiddin Z, Toh EM. Analysis of first forty Oxford medial unicompartmental knee replacements from a small district hospital in UK. Knee. Publication 40 knees 2004; 11:375-377. 25 100% at a mean of 7.5 years Kort et al. The Oxford phase III unicompartmental knee replacement in patients less than 60 years of age. Knee Surg Sports Traumatol Arthrosc. 2007 Publication 46 knees Apr;15(4):356-60. Epub 2006 Oct 7. 26 96% at for cases with follow up between 2 and 6 years Lim, HC et al. Oxford phase 3 unicompartmental knee replacement in Korean patients. JBJS. 2012 Aug; 94-B(8) 27 Publication 400 knees 94% at 10 years Lisowski, LA et al. Oxford Phase 3 unicompartmental knee arthroplasty: medium term results of a minimally invasive surgical procedure. Knee Surg Publication 244 knees Sports Traumatol Arthrosc. 2011; 19:277-84 (Biomet Author) 28 94.4% at 7 years Lloyd, JM et al. Medium term results of per-operative knee arthroscopy in confirming suitability for unicompartmental arthroplasty. The Knee. Publication 151 knees 2012:908-912 29 97.5% at a mean of 5.1 years

Sources Type (NJR, Publications etc.) N (All patients are Oxford partial knees unless stated otherwise) Survivorship Lombardi, AV et al. Is recovery faster for mobile-bearing unicompartmental than total knee arthroplaty? Clin Orthop Relat Res. 2009 Jun;467(6):1450-7 30 Publication 115 knees 94% at a mean of 30 months Matharu, G et al. The Oxford medial unicompartmental knee replacement: survival and the effect of age and gender. The Knee. 2012: 913-917 31 Publication 459 knees 93% at 8 years Murray, DW et al. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. Journal of Bone and Joint Surgery. 1998;80-B:983-989 32 Publication 143 knees 98% at 10 years Pandit, H et al. Minimally invasive Oxford phase 3 unicompartmental knee replacement. Results of 1000 cases. J Bone Joint Surg Br. 2011;93-B:198-204 33 Publication 1,000 knees 96% at 10 years Price AJ, Waite JC, Svard U. Long-term clinical results of the medial Oxford unicompartmental knee arthroplasty. Clin Orthop Relat Res. 2005; 435:171-180 14 Publication 439 knees 93% at 15 years Price, AJ and Svard, U. A second decade lifetable survival analysis of the Oxford unicompartmental knee arthroplasty. Clin Orthop Relat Res. 2011;469:174-179 2 Publication 682 knees 91.0% at 20 years Rajasekhar C, Das S, Smith A. Unicompartmental knee arthroplasty. 2- to 12-year results in a community hospital. J Bone Joint Surg Br. 2004; 86:983-985. 34 Publication 135 knees 94.04% at 10 years Smith, et al. Accelerated rehabilitation following Oxford unicompartmental knee arthroplasty: five year results from an independent centre. Eur J Orthop Traumatol Publication 225 knees 2012; 22: 151-158. 35 95% at 5 years Sun, PF and Jia YH. Mobile bearing UKA compared to fixed bearing TKA: a randomized prospective study. The Knee. 2012;19:103-106 36 Publication 28 knees 100% at a mean of 52 months (after adjusting for learning curve) Svard UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. JBJS. 2000 37 Publication 124 knees 95.0% at 10 years White, Stephen H., Sharon Roberts, and Peter W. Jones. The twin peg Oxford partial knee replacement: the first 100 cases. The Knee 19.1 (2012): 36-40. 38 Publication 100 knees 100% at 2 years Yoshida, Kenjiro, et al. Oxford Phase 3 Unicompartmental Knee Arthroplasty in Japan Clinical Results in Greater Than One Thousand Cases Over Ten Years. Publication 1,279 knees The Journal of arthroplasty 28.9 (2013): 168-171. 39 95% at 10 years

References * Study included Oxford Partial Knees as well as other non-biomet partial knees 1. Data on file 2. Price AJ, Svard U.: A second decade lifetable survival analysis of the Oxford unicompartmental knee arthroplasty. Clin Orthop Relat Res. 2011 Jan;469(1): 174-9. 3. Goodfellow, J. and O Connor, J. The Mechanics of the Knee and Prosthesis Design. Journal of Bone and Joint Surgery (Br). 60(3):358 69, 1978. 4. Psychoyios, V et al. Wear of Congruent Meniscal Bearings in Unicompartmental Knee Arthroplasty. JBJS Br. (1998) 80-B: 876-82. 5. Kendrick, B.J.L. et al. Polyethylene wear of mobile-bearing unicompartmental knee replacement at 20 years. J Bone Joint Surg [Br] 2011;93-B:470-5. 6. Study by researchers at Washington University in St. Louis, Missouri, US. Portions of study funded by Biomet. Determined based on adjusted odds ratio calculation. 7. Biomet Oxford vs. TKA Satisfaction Survey. March, 2012. 8. Brown, NM, et al. Total Knee Arthroplasty Has Higher Postoperative Morbidity Than Unicompartmental Knee Arthroplasty: A Multicenter Analysis. The Journal of Arthroplasty. (2012) 9. Hurst JM et al. Radiographic Comparison of Mobile-Bearing Partial Knee Single-Peg versus Twin-Peg Design. The Journal of Arthroplasty. Available online since October 2014 10. Lygre, SHL et al. Pain and Function in Patients After Primary Unicompartmental and Total Knee Arthroplasty. Journal of Bone and Joint Surgery Am. 2010; 92:2890-2897. 11. Cobb, J, et al. Functional Assessment of knee arthroplasty using an instrumented treadmill. Imperial College of London. March 8, 2012. Presentation. 12. Svard, U. and Price, A. Oxford Medial 1. Unicompartmental Knee Arthroplasty. A Survival Analysis of an Independent Series. Journal of Bone and Joint Surgery. 83:191 194. 2001. 13. Price, A. et al. Long-term Clinical Results of the Medial Oxford Unicompartmental Knee Arthroplasty. Clinical Orthopedics and Related Research. 435:171 180. 2005 14. Price, A.J et al. 10 year in vivo wear measurement of a fully congruent mobile bearing unicompartmental knee arthroplasty. JBJS(Br) 87(11), 1493-1497. 2005. 15. Psychoyios, V et al. Wear of congruent meniscal bearings in unicompartmental knee arthroplasty. JBJS(Br). 80,876-882. 1998 16. Berend, K.R et al. Does Preoperative Patellofemoral Joint State Affect Medial Unicompartmental Arthroplasty Survival? Orthopedics, 34(9), 494-496. 2011. 17. Beard D.J et al. The influence of the presence and severity of preexisting patellofemoral degenerative changes on the outcome of the Oxford medial unicompartmental knee replacement. JBJS(Br), 89(12), 1597-1601. 2007. 18. Ming GL et al. Mobile vs. fixed bearing unicondylar knee arthroplasty: A randomized study on short term clinical outcomes and knee kinematics. The Knee: 365-370. 2006. 19. Berend, M.E.. Mobile Bearing Partial Knee Arthroplasty. Presented at AAOS 2013, Chicago, IL, USA. 20. Bergeson, AG et al. Medial mobile bearing unicompartmental knee arthroplasty early survivorship and analysis of failures in 1000 consecutive cases. Journal of Arthroplasty. 2013 21. Carr, A. et al. Medial Unicompartmental Arthroplasty: A Survival Study of the Oxford Meniscal Knee. Clinical Orthopedics and Related Research. 295:205 213. 1993. 22. Faour-Martin, O. et al. Oxford phase 3 unicondylar knee arthroplasty through a minimally invasive approach: long term results. International Orthopaedics, 2013. 23. Gondusky, Joseph S., et al. Day of Surgery Discharge after Unicompartmental Knee Arthroplasty: An Effective Perioperative Pathway. The Journal of arthroplasty (2013). 24. Jones, L et al. 10 year survivorship of the medial oxford unicompartmental knee arthroplasty. A 1000 patient non-designer series- the effect of surgical grade and supervision. Osteoarthritis and Cartilage. 2012;20:S290-S291 25. Keys GW, Ul-Abiddin Z, Toh EM. Analysis of first forty Oxford medial unicompartmental knee replacements from a small district hospital in UK. Knee. 2004; 11:375-377. 26. Kort et al. The Oxford phase III unicompartmental knee replacement in patients less than 60 years of age. Knee Surg Sports Traumatol Arthrosc. 2007 Apr;15(4):356-60. Epub 2006 Oct 7. 27. Lim, HC et al. Oxford phase 3 unicompartmental knee replacement in Korean patients. JBJS. 2012 Aug; 94-B(8) 28. Lisowski, LA et al. Oxford Phase 3 unicompartmental knee arthroplasty: medium term results of a minimally invasive surgical procedure. Knee Surg Sports Traumatol Arthrosc. 2011; 19:277-84 (Biomet Author) 29. Lloyd, JM et al. Medium term results of per-operative knee arthroscopy in confirming suitability for unicompartmental arthroplasty. The Knee. 2012:908-912 30. Lombardi, AV et al. Is recovery faster for mobile-bearing unicompartmental than total knee arthroplaty? Clin Orthop Relat Res. 2009 Jun;467(6):1450-7 31. Matharu, G et al. The Oxford medial unicompartmental knee replacement: survival and the effect of age and gender. The Knee. 2012: 913-917 32. Murray, DW et al. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. Journal of Bone and Joint Surgery. 1998;80-B:983-989 33. Pandit, H, et al: The Oxford medial unicompartmental knee replacement using a minimally-invasive approach. JBJS (BR), Jan 2006; 88B: 54-60. 34. Rajasekhar C, Das S, Smith A. Unicompartmental knee arthroplasty. 2- to 12-year results in a community hospital. J Bone Joint Surg Br. 2004; 86:983-985. 35. Smith, et al. Accelerated rehabilitation following Oxford unicompartmental knee arthroplasty: five year results from an independent centre. Eur J Orthop Traumatol 2012; 22: 151-158. 36. Sun, PF and Jia YH. Mobile bearing UKA compared to fixed bearing TKA: a randomized prospective study. The Knee. 2012;19:103-106 37. Svard UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. JBJS. 2000 38. White, Stephen H., Sharon Roberts, and Peter W. Jones. The twin peg Oxford partial knee replacement: the first 100 cases. The Knee 19.1 (2012): 36-40. 39. Yoshida, Kenjiro, et al. Oxford Phase 3 Unicompartmental Knee Arthroplasty in Japan Clinical Results in Greater Than One Thousand Cases Over Ten Years. The Journal of arthroplasty 28.9 (2013): 168-171. All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet s website. The Oxford Partial Knee is intended for osteoarthritis or avascular necrosis limited to the medial knee compartment and is to be implanted with bone cement. The Oxford Knee is not indicated for use in the lateral compartment or for patients with ligament deficiency. Potential risks include, but are not limited to, loosening, dislocation, fracture, wear, and infection, any of which can require additional surgery. For complete prescribing information, see the package insert and www.biomet.com. Responsible Manufacturer Biomet UK Limited Waterton Industrial Estate Bridgend CF31 3XA United Kingdom 2015 Biomet Orthopedics Form No. BMET00508.2 REV0515 www.biomet.com