The Journal of Bone and Joint Surgery (American). 2009;91 A Prospective, Randomized Controlled Trial Karen A. Bettinson, MSc, RN1, Ian M. Pinder, FRCS2, Chris G. Moran, MD, FRCS(Ed)3, David J. Weir, FRCS(Orth)1 and Elizabeth A. Lingard, BPhty, MPhil, MPH1
Background: Several studies have described equivalent performance on radiostereometric analysis at two years for metal-backed compared with all-polyethylene stemmed tibial implants. The purpose of this study was to determine the ten-year survivorship results of these two designs from a large randomized controlled trial. Methods: Patients who were fifty years old or more, with no history of infection, and were undergoing primary total knee arthroplasty were randomized at the time of surgery to receive either an all-polyethylene or a metal-backed tibial component. Patients were assessed preoperatively and at one, three, five, eight, and ten years postoperatively. All assessments included a clinical history, a physical examination, and a radiographic evaluation. A total of 510 consecutive patients (566 knees) were recruited from August 1993 to January 1997. The mean age of the patients at the time of the index arthroplasty was 69.3 years, and 299 (59%) were women. The primary diagnosis was osteoarthritis for 458 knees (80.9%) and rheumatoid arthritis for 108 knees (19.1%). Results: Two hundred and ninety-three patients returned for the ten-year follow-up evaluation. A total of twenty-eight knees had been revised. Ten-year survivorship, with revision for any reason (or the time at which patients were documented as requiring revision but were unfit for surgery) as the end point, was 94.5% (95% confidence interval, 90.4% to 96.8%) for the all-polyethylene design and 96% (95% confidence interval, 92.6% to 97.8%) for the metal-backed design. Ten-year survivorship, with aseptic failure as the end point, was 97% (95% confidence interval, 93.3% to 98.7%) for the all-polyethylene design and 96.8% (95% confidence interval, 93.6% to 98.4%) for the metal-backed design. On the basis of the numbers available at ten years, there was no significant difference in survivorship between the two designs (p > 0.05). Conclusions: The long-term results demonstrate excellent survivorship, with revision as the end point, for both the metal-backed and the all-polyethylene tibial component designs with no differences noted between the two. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.