Arthritis of the Knee Joint Clinical Trial
Should my New Knee Rotate? A Randomised, Controlled Clinical Trial to Compare Fixed and Mobile Bearing Total Knee Arthroplasties Using the SCORPIO PS and SCORPIO+ PS Knee Systems
Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to relieve pain, restore function and correct deformity. It is a very common surgical procedure with figures showing more than 500'000 arthroplasties performed annually worldwide. Total knee arthroplasty is considered one of the most successful types of joint reconstruction in that surgical results usually meet and even exceed expectations. Much of the current literature focuses on the issues relating to implant wear as a potential failure mode for artificial knee implants. It has been suggested that knee with mobile or rotating bearing options, such as the comparative device proposed for this clinical investigation, may survive longer than fixed bearing knee designs because of the greater contact surface area possible with more congruent components with unconstrained, mobile component design.
This is a prospective, comparative, randomised, open-label, single center, multiple surgeons
clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be
implanted for evaluation in this study. Patients will be randomised to one of two equal sized
groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in
the second group patients will be treated with the Scorpio PS mobile bearing implant.
Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively. ;
|Source||Maastricht University Medical Center|
|Start date||September 2003|
|Completion date||December 2011|