Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray

NCT ID: NCT00734019

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-01
• Study Completion Date: 2020-03-09

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.

Conditions

Knee Osteoarthritis

Keywords

Arthroplasty, Replacement, Knee, TKR, PFC Sigma

Study Groups

P.F.C. Sigma Knee System

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

Intervention Type: DEVICE

Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asklepios Klinic/ Lindenlohe Orthopeadic Hospital

Schwandorf in Bayern, Deutschland, Germany

Hospital S Antonìo Of Padova

Padua, , Italy

Princess Alexandra Hospital

Harlow, Essex, United Kingdom

Queen Margaret Hospital

Dunfermline, Fife, United Kingdom

Arrowe Park Hospital

The Wirral, Merseyside, United Kingdom

Countries

Germany; Italy; United Kingdom

Other Identifiers

CT 04/16

Identifier Type: -

Identifier Source: org_study_id