A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: PFC Sigma RP-F; PFC Sigma RP
Intervention description: An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing; An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Arthroplasty; Replacement; Knee; PFC Sigma RPF; PFC Sigma RP

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, aged between 45 and 75 years inclusive.

          -  Subjects who are able to give voluntary, written informed consent to participate in
             this clinical investigation and from whom consent has been obtained.

          -  Subjects who, in the opinion of the Clinical Investigator, are able to understand this
             clinical investigation, co-operate with the investigational procedures and are willing
             to return to the hospital for all the required post-operative follow-ups.

          -  Subjects who present with osteoarthritis that in the opinion of the clinical
             investigator requires a primary total knee arthroplasty.

          -  Subjects who in the opinion of the Clinical Investigator are considered to be suitable
             for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according
             to the indications specified in the package insert leaflet.

          -  Subjects who have authorised the transfer of his/her pseudonymised information to
             DePuy.

        Exclusion Criteria:

          -  Subjects who, in the opinion of the Clinical Investigator, have an existing condition
             that would compromise their participation and follow-up in this clinical
             investigation.

          -  Female subjects who are pregnant or lactating.

          -  Subjects who are known drug or alcohol abusers or with psychological disorders that
             could affect follow-up care or treatment outcomes.

          -  Subjects who have participated in a clinical investigation with an investigational
             product in the last month( 30 days).

          -  Subjects who are currently involved in any injury litigation claims.

          -  Subjects with a known history of poor compliance to medical treatment.

          -  Subjects who have previously had an osteotomy or significant surgery in the affected
             knee.