Purpose: As part of the step-wise introduction of a meniscal-bearing total knee replacement (Oxford TMK) we needed to know, before proceeding to longer term studies, whether its early clinical results were at least as good as those of an established fixed bearing device (AGC).

Material and Methods: With ethical approval, patients requiring bilateral knee replacement for osteoarthritis consented to have the operations under one anaesthetic using one of each prosthesis; to accept random choice of knee; and to remain ignorant which side was which. American Knee Society Scores, Oxford Knee Scores, ROM and pain scores were to be recorded preoperatively and at one year. By January 2001, 40 patients had reached one year and data is available for 36.

Results: Preoperatively there was no difference between the two knees. One patient died in the peri-operative period.

Results at one year (TMK first): AKSS(Knee) 91.6 / 84.1 (p=0.003), OKS 39.8 / 37.6 (p=0.006), ROM 104 / 104 (p=0.364), Pain (AKSS) 47.3 / 41.7 (p=0.01), Pain (OKS) 3.5 / 2.9 (p=0.006).

Conclusion: The TMK performed as well as the AGC. Its AKSS, OKS and pain scores were significantly better. We believe this controlled, blinded trial is the first to have compared the function of a new knee prosthesis with a standard implant before marketing; and the first to have demonstrated a significant clinical advantage for a meniscal-bearing over a fixed bearing TKR. The comparison of bilateral implants in the same patient can reveal significant differences while putting at risk many fewer subjects than would be needed for a classical twocohort RCT.