PFC Sigma Fixed and Mobile Knee Study

This study has been terminated.
(The study was terminated at the point the primary endpoint and early milestones were reached and because long term outcomes were available from other sources)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208325
First received: September 13, 2005
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Device: P.F.C Sigma Fixed Bearing total knee system
Device: P.F.C Sigma RP Mobile Bearing knee system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Active range of knee motion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annual joint survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 683
Study Start Date: May 1999
Estimated Study Completion Date: July 2022
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Fixed bearing
Device: P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
Experimental: 2
Mobile bearing
Device: P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208325

Locations
United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Glasgow Western Infirmary
Glasgow, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1LB
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael Borroff, BSc, MSc DePuy International ltd
Principal Investigator: Mr Peter James, FRCS Nottingham City Hospital
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208325     History of Changes
Other Study ID Numbers: CT 9923
Study First Received: September 13, 2005
Last Updated: May 29, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014