Clinical trial NCT00734019: Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Arthroplasty, Replacement, Knee, TKR, PFC Sigma
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life.
timeFrame: 3 month, 1,3, 5 and 10 years
Other outcomes:
Locations:
city: Schwandorf
country: Germany
facility: Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
state: Deutschland
city: Padova
country: Italy
facility: Hospital S Antonìo Of Padova
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
state: Essex
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital
state: Fife
city: The Wirral
country: United Kingdom
facility: Arrowe Park Hospital
state: Merseyside
Study officials:
References: