A Randomized Controlled Trial Comparing a Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcomes Following Total Knee Replacement.

Abstract

The purpose of this randomized controlled trial was to compare the performance of 3 total knee joint replacement (TKJR) designs 6 months after the surgery. Patients were recruited between March 2015 and March 2018. Patients with osteoarthritis consented for TKJR were randomly allocated to a medial stabilized (MS), cruciate retaining (CR), or posterior stabilized (PS) design. Primary outcome measures were self-reported improvement in pain and function 6 months after TKJR, using the Oxford Knee Score. Secondary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index, Veterans RAND 12-item Health Survey, Knee Society Score 2011, Timed Up and Go test, and Six-Minute Walk Test. Twelve-month outcomes were also measured. Ninety participants enrolled, 83 were randomized: PS (n = 26), CR (n = 28), and MS (n = 29) designs. One case withdrew before surgery: planned use of non-study implant; 7 did not complete all outcome measures. No 6-month between-group difference was observed for the primary outcome. A 6-month difference was observed in Knee Society Score 2011 Satisfaction: MS favored over CR and PS. Clinically meaningful 12-month differences in Western Ontario and McMaster Universities Osteoarthritis Index Pain, Function, and Global Subscales were observed: MS favored over CR. Twelve-month differences occurred in Veterans RAND 12-item Health Survey mental well-being, favoring MS and PS over CR. MS prosthesis can be expected to yield similar clinical and functional outcomes to PS and CR designs 6 months after TKJR, and patients were more satisfied with their outcome. Compared with CR, patients with MS prosthesis also reported superior pain, function, and quality-of-life outcomes at 12 months.