Comparison Study of Medial Pivot Versus Single Radius Knee Implants for Total Knee Replacement in Adults with Osteoarthritis

What this Trial Is About

Researchers are evaluating two types of knee implant designs for adults with degenerative joint disease who need primary total knee replacement surgery. The study compares the medial pivot design and single radius design implants, aiming to understand which may better restore normal knee motion, improve clinical outcomes, and increase patient satisfaction. This research includes clinical outcomes, patient-reported outcomes, and detailed gait function analysis using a specialized laboratory. Participants will receive one of the two implant systems: the MicroPort Evolution Medial-Pivot Knee System or the Stryker Triathlon Tritanium Knee System with a single radius design. The study is conducted at a single center with 100 adult subjects undergoing primary total knee arthroplasty. Follow-up visits are scheduled before surgery, at 6 weeks, and then at 6, 12, 24, 36, and 60 months post-operation to monitor progress and outcomes. During the study, participants will undergo clinical exams, patient questionnaires, and detailed gait laboratory assessments including measurements of knee mechanics, knee translation, muscle strength, range of motion, and various functional mobility tests. These assessments occur pre-operatively and at 3 and 12 months post-operatively. The study tracks changes over time to evaluate implant performance and overall function, while participants adhere to the required follow-up visits and standard clinical care.

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty