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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 51 - 51
1 May 2016
Brenkel I Graichen H Himden S Murphy J Parkinson R
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Introduction

Cross-linked polyethylene in total hip arthroplasty has demonstrated excellent long-term wear resistance, leading to its acceptance as the standard bearing used in hip replacement. Adoption in knee replacement has been tentative, as the cross-linking process can decrease the polyethylene mechanical properties. The current study's purpose was examining survivorship of a fixed bearing knee replacement system featuring a moderately cross-linked polyethylene (MXLK) bearing, a cobalt chrome (CoCr) tibial tray with a highly polished top surface, and a new polyethylene-to-tray locking mechanism. The MXLK is made of ultra-high molecular weight GUR1020 resin irradiated with 5 Mrad gamma radiation, followed by a free radical quenching remelting annealing process, above the 135 degree melting point, that provides wear and fatigue resistance, and oxidative stability.

Materials & Methods

From November 2005 to June 2008, 539 PFC Sigma primary total knee replacements (TKA's) were prospectively entered into this non-comparative, multicenter, multinational study. Average age at time of surgery was 67 years, 57% were female, average body mass index was 30.4 kg/m2, and the dominant diagnosis was osteoarthritis (97%). Kaplan-Meier (KM) survivorship was the primary endpoint with primary event definition being removal of any component for any reason. The time variable was one of the following: time to revision, time to death, or time to last follow-up. Additional endpoints included: American Knee Society scores (knee and function), Oxford Knee score (range 12 to 60), SF-12 scores; radiographically assessed rates of radiolucent lines (RLL's) and osteolysis. RLL's greater than 2mm were counted. Progressive RLL's were those increasing in width from an earlier follow-up interval. Adjacent RLL's were defined as RLL's in adjacent zones. Complete RLL's were defined as RLL's completely around a component. This report provides 5-year results in this ongoing study with a 10-year final endpoint.