Status:
TERMINATED
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the i...
Detailed Description
Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of healt...
Eligibility Criteria
Inclusion
- Male or female subjects over the age of 21 years (and skeletally mature).
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- 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.
- Subjects whose primary diagnosis includes non-inflammatory or inflammatory degenerative joint disease.
- Subjects who require revision of any previous knee arthroplasty.
- Subjects who, in the opinion of the Clinical Investigator, are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
- Subjects who require revision of the femoral and/or tibial components. (Both components must be replaced as part of the study.)
Exclusion
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study (including malignancy, severe osteoporosis or disabling musculoskeletal problems).
- Women who are pregnant.
- 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 study with an investigational product in the last 60 days (excluding any primary knee replacement study).
- Subjects who are currently involved in any injury litigation claims.
- Subjects with global instability, deficient extensor mechanism or severe bone loss (eg. due to fracture or tumour resection).
- Subjects who have had their contralateral knee replaced within the previous 6-month period.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00733681
Start Date
March 1 2004
End Date
March 1 2014
Last Update
January 22 2015
Active Locations (9)
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1
CHU
Amiens, France
2
Orthopaedische Universitaetsklinik
Heidelberg, Germany, D-69118
3
Asklepios Klinik
Lindenlohe, Germany
4
Geneva University Hospital
Geneva, Switzerland