초록/요약

Background: We are aware of no study that has compared press-fit condylar Sigma fixed-bearing and mobile-bearing total knee prostheses in the same patients after more than ten years of follow-up. The purpose of the current study was to compare these two implants with respect to the functional and radiographic results, prevalence of osteolysis, and overall revision rates at a mean of 12.1 years of follow-up. Methods: The study consisted of a consecutive series of 444 patients (mean age [and standard deviation], 66.5 +/- 7.4 years) who underwent simultaneous bilateral total knee arthroplasty, with one side treated immediately after the other. All of the patients received a press-fit condylar Sigma mobile-bearing prosthesis on one side and a press-fit condylar Sigma fixed-bearing prosthesis on the contralateral side. The minimum duration of follow-up was ten years (mean, 12.1 years; range, ten to thirteen years). At the time of each follow-up visit, the patients were assessed clinically and radiographically. Results: Postoperative total knee scores (95 and 94 points), Western Ontario and McMaster Universities Osteoarthritis Index (19 and 18 points), University of California, Los Angeles activity score (both prostheses, 5 points), range of motion (129 degrees +/- 6.3 degrees and 127 degrees +/- 6.8 degrees), and radiographic findings did not differ significantly between the press-fit condylar Sigma mobile and fixed-bearing designs at the final follow-up. The prevalence of aseptic loosening (1.4% and 1.8%) did not differ significantly between the mobile and fixed-bearing implant designs. No knee in either group had osteolysis. The estimated survival rate with revision as the end point was 98.2% (95% confidence interval, 91% to 99%) and 97.5% (95% confidence interval, 91% to 99%) at 12.1 years for the mobile and fixed-bearing implant groups, respectively. Conclusions: The results of the present long-term clinical study suggest that excellent clinical and radiographic results were achieved with both the press-fit condylar Sigma mobile and fixed-bearing cruciate-retaining total knee designs. We found no significant clinical advantage for a mobile-bearing over a fixed-bearing total knee prosthesis.