PFC Sigma Fixed and Mobile Knee Study

Osteoarthritis, Knee Clinical Trial

Official title:

Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208325
• Other study ID #: CT 9923
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 29, 2013
• Start date: May 1999
• Est. completion date: July 2022

Study information

• Verified date: May 2013
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.

Description:

The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 683
• Est. completion date: July 2022
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects may be recruited to the evaluation.

2. Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.

3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

5. Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.

6. Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing.

Exclusion Criteria:

1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

2. Patients who require revision total knee arthroplasty surgery.

3. Patients with any tibial deformity requiring tibial component augmentation.

4. Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.

5. Patients with Rheumatoid Arthritis.

6. Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.

7. Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.

8. Contra-indications for use of the device, as detailed in the package insert.

9. Women who are pregnant.

10. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

11. Subjects who are currently involved in another clinical study with an investigational product.

12. Subjects who are currently involved in any injury litigation claims.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
• P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Glasgow Western Infirmary	Glasgow
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Nottingham City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active range of knee motion		1 year	No
Secondary	Annual joint survival		10 years	Yes