Status:
TERMINATED
P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient...
Detailed Description
Performance and safety will be assessed using the following surgeon and patient based outcome tools: 1. American Knee Society Knee and Function Scores 2. Knee Society Radiological Analysis 3. Oxford ...
Eligibility Criteria
Inclusion
- Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime.
- 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.
- Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation.
- Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
- Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing.
Exclusion
- Patients with rheumatoid arthritis.
- Patients requiring revision total knee arthroplasty surgery.
- Patients with any tibial deformity requiring tibial component augmentation.
- Patients that in the opinion of the clinical investigators require a constrained prosthesis.
- Patients with a known history of poor compliance to medical treatment.
- Patients who are known drug or alcohol abusers.
- Patients with a pathology which in the opinion of the clinical investigator will adversely affect healing.
- Patients who are currently participating in another clinical evaluation.
- Patients with other disorders which in the opinion of the Clinical Investigator will / could impair rehabilitation.
- Contra-indications for use of the device, as detailed in the package insert.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00208286
Start Date
November 1 2001
End Date
March 1 2015
Last Update
June 20 2016
Active Locations (1)
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1
Middlesborough General Hospital
Middlesbrough, United Kingdom