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

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.

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: P.F.C. Sigma Knee

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.

• Study Type: Observational
• Enrollment (Actual): 650

Contacts and Locations

Study Locations

• Germany
  • Deutschland
    • Schwandorf, Deutschland, Germany
      • Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
• Italy
  • Padova, Italy
    • Hospital S Antonìo Of Padova
• United Kingdom
  • Essex
    • Harlow, Essex, United Kingdom, CM20 1QX
      • Princess Alexandra Hospital
  • Fife
    • Dunfermline, Fife, United Kingdom, KY12 0SU
      • Queen Margaret Hospital
  • Merseyside
    • The Wirral, Merseyside, United Kingdom, CH49 5PE
      • Arrowe Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life.	3 month, 1,3, 5 and 10 years

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2005
• Primary Completion (Actual): July 3, 2019
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Arthroplasty, Replacement, Knee, TKR, PFC Sigma
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CT 04/16