This trial is active, not recruiting.

Condition knee osteoarthritis
Treatment p.f.c. sigma knee
Phase phase 4
Sponsor DePuy International
Start date October 2005
End date December 2017
Trial size 650 participants
Trial identifier NCT00734019, CT 04/16


The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert.
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

Primary Outcomes

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

Secondary Outcomes

Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life.
time frame: 3 month, 1,3, 5 and 10 years

Eligibility Criteria

Male or female participants up to 80 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title 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.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by DePuy International.