Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System

Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System

The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery.

In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: P.F.C. Sigma Total Knee System

Detailed Description

The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.

• Study Type: Interventional
• Enrollment (Actual): 723
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Harlow, Essex, United Kingdom, CM20 1QX
      • Princess Alexandra Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have given voluntary written informed consent to participate in this study.
• Patients 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.
• Patients 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 the scheduled post-operative follow-ups.
• Male or female patients who are skeletally mature and for whom an appropriate size of device is available.

Exclusion Criteria:

• Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
• Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
• Patients 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.).
• Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
• Patients having non-contained defects in the tibia or femur necessitating bone graft.
• Patients with psychosocial disorders that would limit rehabilitation or follow-up.
• 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 Knee System as listed in the package insert.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P.F.C. Sigma Total Knee Replacement System; Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System.	Device: P.F.C. Sigma Total Knee System; An orthopaedic implant for total knee replacement; Other Names: Sigma Fixed Bearing Total Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.	6 weeks, 1, 2, 5 years

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2000
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CT 99/24