A Study to Determine the Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 11, 2008
Last updated: September 12, 2012
Last verified: September 2012
The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.
Device: P.F.C. Sigma Knee
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective, Non-comparative, Multicentre, Multinational Study to Determine the Survivorship of the P.F.C. Fixed Bearing Knee System Using a Moderately Cross-linked Polyethylene Insert and a Cobalt Chrome Tibial Tray.
Primary Outcome Measures:
- The primary endpoint is a survivorship analysis of the P.F.C. fixed bearing knee system with a cobalt chrome tibial tray and moderately cross linked polyethylene insert at the five-year time point. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life. [ Time Frame: 3 month, 1,5 and 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
P.F.C. Sigma Knee
Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert.
Device: P.F.C. Sigma Knee
Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert
The primary objective of this study is to assess the survivorship of the P.F.C. fixed bearing knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert at 5-Years. The secondary objectives of this investigation are to evaluate additional clinical outcomes to provide further information on the performance of the P.F.C. fixed bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome tibial tray. These outcomes will include Radiographic assessment, American Knee Society Score, Oxford Knee Score and SF-12.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects who have given voluntary written informed consent to participate in this study
- Subjects 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.
- Subjects 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 scheduled post-operative follow ups.
- Male or Female subjects who are skeletally mature and for whom an appropriate size of device is available
- The following subjects are not considered eligible and must not be recruited to the investigation
- Subjects scheduled for revision total knee arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
- Subjects aged over 80 Years
- Subjects experiencing any condition that may, in the opinion of the investigator, interfere with the total knee replacements survival or outcome (e.g. Pagets disease, Charcots disease, severe osteoporosis etc).
- Subjects 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)
- Subjects who are currently participating in any other clinical investigation of a device or pharmaceutical.
- Subjects having non-contained defects in the tibia or femur necessitating bone graft.
- Subjects with psychosocial disorders that would limit rehabilitation
- 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 fixed bearing knee system as listed in the package insert.
- Women who are pregnant
- Subjects who are currently involved in any injury litigation claims
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734019
|Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
|Schwandorf, Germany |
|Hospital S Antonìo Of Padova
|Padova, Italy |
|Princess Alexandra Hospital
|Harlow, Essex, United Kingdom, CM20 1QX |
|Queen Margaret Hospital
|Kirkcaldy, Fife, United Kingdom, KY12 0SU |
|Arrowe Park Hospital
|The Wirral, United Kingdom |
||Ivan Brenkel, FRCS
||Queen Victoria Hospital, Fife
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 11, 2008
||September 12, 2012
||United Kingdom: Research Ethics Committee
Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee, TKR, PFC Sigma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Physiological Effects of Drugs