Osteoarthritis, Knee Clinical Trial
Official title:
An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems
Primary Research Questions:
1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a
Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e.
quality of life, function, range of motion) than similar patients who undergo total
knee arthroplasty (TKA) using the Sigma fixed bearing knee?
2. Do patients with knee OA who undergo TKA with a Sigma rotating platform have different
knee kinetics and kinematics as measured by gait analysis than similar patients who
undergo TKA using the Sigma fixed bearing knee?
3. Do patients with knee OA who undergo TKA with or without computer assistance have
better clinical outcomes at two years following surgery (quality of life, function,
range of motion)?
4. Do patients with knee OA who undergo TKA with or without computer assistance have
different knee kinematics and kinetics as measured by gait analysis?
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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