Knee Osteoarthritis Clinical Trial
Official title:
A Prospective, Single Blinded, Multi-centre Randomised Controlled Trial Comparing the Post Operative Range of Motion of the P.F.C. Sigma RP-F Knee With the P.F.C. Sigma RP Knee in Primary Total Knee Arthroplasty.
The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a
greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in
primary TKA.
The secondary objectives of this investigation are to evaluate the clinical and patient
outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior
Stabilised (PS) Knee over 5 years.
Primary Outcome: change from pre-operative range of motion at 1 year between patients
receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F
Secondary endpoints: Comparative evaluation of any post-operative variation between subjects
receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis
Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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