Status:
TERMINATED
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
Lead Sponsor:
DePuy International
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to asse...
Detailed Description
The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.
Eligibility Criteria
Inclusion
- Patients who have given voluntary written informed consent to participate in this study.
- Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
- Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
- Male or female patients who are skeletally mature and for whom an appropriate size of device is available.
Exclusion
- Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
- Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
- Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
- Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
- Patients having non-contained defects in the tibia or femur necessitating bone graft.
- Patients with psychosocial disorders that would limit rehabilitation or follow-up.
- Subjects with a known history of poor compliance to medical treatment.
- Subjects who are known drug or alcohol abusers.
- Other contraindications for the use of the P.F.C. ® S Knee System as listed in the package insert.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
723 Patients enrolled
Trial Details
Trial ID
NCT00734110
Start Date
July 1 2000
End Date
June 1 2010
Last Update
October 10 2025
Active Locations (1)
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1
Princess Alexandra Hospital NHS Trust
Harlow, Essex, United Kingdom, CM20 1QX