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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00734110
• Other study ID #: CT 99/24
• Status: Terminated
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: June 5, 2015
• Start date: July 2000
• Est. completion date: June 2010

Study information

• Verified date: June 2015
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 723
• Est. completion date: June 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• P.F.C. Sigma Total Knee System
An orthopaedic implant for total knee replacement

Locations

Country	Name	City	State
United Kingdom	Princess Alexandra Hospital NHS Trust	Harlow	Essex

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals		5 years	No
Secondary	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	No