PFC Sigma Fixed and Mobile Knee Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: P.F.C Sigma Fixed Bearing total knee system; P.F.C Sigma RP Mobile Bearing knee system
Intervention description: Orthopaedic implant for total knee replacement; Orthopaedic implant for total knee replacement
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 754.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this investigation is to evaluate the performance (in terms of
      post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma
      Rotating Platform total knee systems in clinical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects may be recruited to the evaluation.

          2. Age - there are no restrictions relating to age of the patient. The patient's age must
             be considered suitable by the clinical investigator for a bi-compartmental or
             tri-compartmental knee arthroplasty using either of the two systems available in the
             evaluation.

          3. Subjects who are able to give voluntary, written informed consent to participate in
             this investigation and from whom consent has been obtained.

          4. Subjects who, in the opinion of the Investigator, are able to understand this
             investigation, co-operate with the investigational procedures and are willing to
             return to the hospital for all the required post-operative follow-ups.

          5. Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for
             primary surgical management of idiopathic osteoarthritis.

          6. Patients who in the opinion of the Clinical Investigator are considered to be suitable
             for treatment with a fixed or mobile bearing knee system and who are suitable for
             patella resurfacing.

        Exclusion Criteria:

          1. Patients who, in the opinion of the Investigator, have an existing condition that
             would compromise their participation and follow-up in this study.

          2. Patients who require revision total knee arthroplasty surgery.

          3. Patients with any tibial deformity requiring tibial component augmentation.

          4. Patients whom, in the opinion of the Clinical Investigator, require a constrained
             prosthesis.

          5. Patients with Rheumatoid Arthritis.

          6. Patients with a pathology which, in the opinion of the Clinical Investigator, will
             adversely affect healing.

          7. Patients with other disorders which, in the opinion of the Clinical Investigator, will
             / could impair rehabilitation.

          8. Contra-indications for use of the device, as detailed in the package insert.

          9. Women who are pregnant.

         10. Subjects who are known drug or alcohol abusers or with psychological disorders that
             could effect follow-up care or treatment outcomes.

         11. Subjects who are currently involved in another clinical study with an investigational
             product.

         12. Subjects who are currently involved in any injury litigation claims.