Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems

This study has been terminated.
(Primary outcome of the study achieved; investigator decided to conduct the study without sponsor support after 2009.)
Information provided by (Responsible Party):
DePuy International Identifier:
First received: September 13, 2005
Last updated: July 15, 2013
Last verified: June 2013

The objective of this clinical evaluation is to compile a long-term clinical profile of the performance and safety of the PFC Sigma and PFC Sigma Rotating Platform total knee systems in normal practice.

Condition Intervention Phase
Osteoarthritis, Knee
Device: PFC Sigma Rotating Platform (Mobile Bearing) TKR
Device: PFC Sigma (Fixed Bearing) TKR
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 Rotating Platform (Mobile Bearing) Total Knee Systems.

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • 1 year range of motion measured through the American Knee Society Score. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

Secondary Outcome Measures:
  • Outcome measures to assess long-term performance. [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    The following outcome measures will be used; Knee Society Score, Knee Society Radiological analysis, Oxford Knee Score, SF-12 and Anterior Knee Pain Socre.

Enrollment: 120
Study Start Date: December 2001
Study Completion Date: October 2009
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PFC Sigma Fixed Bearing Knee System
Device: PFC Sigma (Fixed Bearing) TKR
PFC Sigma Fixed Bearing Total Knee Replacement
Experimental: 2
PFC Sigma RP Mobile Bearing Knee System
Device: PFC Sigma Rotating Platform (Mobile Bearing) TKR
Mobile Bearing Knee Replacement

Detailed Description:

Performance and safety will be assessed using the following surgeon and patient based outcome tools:

  1. Knee Society Score
  2. Knee Society Radiological Analysis
  3. Oxford Knee Score
  4. SF 12 Score
  5. Anterior Knee Pain Score

Specific objectives of the evaluation being to assess the following:

  1. Improvement in functional recovery
  2. Incidence of anterior knee pain
  3. Improvement in Quality of life
  4. Incidence of tibial loosening
  5. Incidence of excessive polyethylene wear

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

Inclusion Criteria:

  1. Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime.
  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. Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation.
  4. Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
  5. Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing.

Exclusion Criteria:

  1. Patients with rheumatoid arthritis.
  2. Patients requiring revision total knee arthroplasty surgery.
  3. Patients with any tibial deformity requiring tibial component augmentation.
  4. Patients that in the opinion of the clinical investigators require a constrained prosthesis.
  5. Patients with a known history of poor compliance to medical treatment.
  6. Patients who are known drug or alcohol abusers.
  7. Patients with a pathology which in the opinion of the clinical investigator will adversely affect healing.
  8. Patients who are currently participating in another clinical evaluation.
  9. Patients with other disorders which in the opinion of the Clinical Investigator will / could impair rehabilitation.
  10. Contra-indications for use of the device, as detailed in the package insert.
  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 identifier: NCT00208286

United Kingdom
Middlesbrough, United Kingdom
Sponsors and Collaborators
DePuy International
Study Director: Michael Borroff, BSc, MSc DePuy International
  More Information

No publications provided

Responsible Party: DePuy International Identifier: NCT00208286     History of Changes
Other Study ID Numbers: CT0101
Study First Received: September 13, 2005
Last Updated: July 15, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 25, 2014