Status:
COMPLETED
The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly
Lead Sponsor:
DePuy International
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA. The se...
Detailed Description
Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tib...
Eligibility Criteria
Inclusion
- Subjects requiring a primary knee replacement.
- Subjects aged 65 years or more.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.
Exclusion
- Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
- Subjects who have had a renal transplant.
- Subjects with a metabolic bone disorder.
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
- Subjects whose contralateral knee is already included in this study.
- Subjects who have a history of active joint sepsis.
- Subjects who have a recent history of high dose systemic corticosteroids.
- Subjects with psycho-social disorders or physical disabilities that would limit rehabilitation.
- Subjects requiring a bone graft.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00733928
Start Date
October 1 1999
End Date
March 1 2015
Last Update
March 30 2025
Active Locations (1)
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1
Department of Orthopaedics, Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN