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

NCT00734110 | Terminated Phase 4

• 1 other identifier: CT 99/24
• Study Type: interventional
• Target: 723
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP

Outcome Measures

Primary Outcomes (1)

• To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals

  5 years

Secondary Outcomes (1)

• 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

Study Arms (1)

P.F.C. Sigma Total Knee Replacement System

EXPERIMENTAL

Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System.

Device: P.F.C. Sigma Total Knee System

Interventions

P.F.C. Sigma Total Knee System DEVICE

An orthopaedic implant for total knee replacement

Also known as: Sigma Fixed Bearing Total Knee System

P.F.C. Sigma Total Knee Replacement System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Princess Alexandra Hospital NHS Trust

Harlow, Essex, CM20 1QX, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: July 1, 2000
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2010
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

GB (1)