Michelle M Dowsey1, Daniel J Gould2, Timothy Spelman2, Marcus G Pandy3, Peter F Choong1. 1. Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia; Department of Orthopaedics, St Vincent's Hospital, Melbourne, Victoria, Australia. 2. Department of Surgery, The University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia. 3. Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.
Abstract
BACKGROUND: 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. METHODS: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. RESULTS: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. CONCLUSION: 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.
RCT Entities:
BACKGROUND: 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. METHODS: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. RESULTS: 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. CONCLUSION: 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.