Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
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Purpose
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 assess the functioning and symptomology of each knee following surgery.
In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Osteoarthritis |
Device: P.F.C. Sigma Total Knee System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System |
- To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported. [ Time Frame: 6 weeks, 1, 2, 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 731 |
| Study Start Date: | October 2000 |
| Estimated Study Completion Date: | October 2014 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
-
Device: P.F.C. Sigma Total Knee System
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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 contrainidcations for the use of the P.F.C. ® S Knee System as listed in the package insert.
Contacts and Locations| United Kingdom | |
| Princess Alexandra Hospital NHS Trust | |
| Harlow, Essex, United Kingdom, CM20 1QX | |
| Principal Investigator: | Paul W Allen, FRCS | Princess Alexandra Hospital, Essex |
More Information
No publications provided
| Responsible Party: | Mick Borroff, DePuy International - (see details above) |
| ClinicalTrials.gov Identifier: | NCT00734110 History of Changes |
| Other Study ID Numbers: | CT 99/24 |
| Study First Received: | August 11, 2008 |
| Last Updated: | February 15, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by DePuy International:
|
Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013