Factors influencing wear and osteolysis in press-fit condylar modular total knee replacements.

The purpose of this study was to determine the factors influencing wear and osteolysis in patients who have had total knee arthroplasty with the Press-Fit Condylar modular system. Two-thousand ninety-one primary total knee replacements in 1737 patients were done using the Press-Fit Condylar system at three centers. Radiographic and manufacturing data were obtained for 2016 of the 2091 implants (96.4%). For the 1287 of 2016 knees (64%) with more than 5 years of followup, the prevalence of wear-related failure was 8.3%. The 13-year survivorship for all patients was 82.6%. Cox hazards analysis revealed five variables that were correlated with wear-related failure: patient age, patient gender, polyethylene sheet vendor, polyethylene finishing method, and polyethylene shelf age. We were unable to identify one factor as the defining reason for these wear-related failures. The multiple changes in manufacturing methods during the life of this implant may have precluded such a determination. These results may be specific to inserts sterilized in air with gamma irradiation and should not be generalized to current manufacturing techniques. This study emphasizes the potential deleterious effects that small changes in the manufacturing process may have on the outcome of a prosthesis with an initially favorable survivorship.