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The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733928
First received: August 11, 2008
Last updated: May 27, 2016
Last verified: May 2016
  Purpose

The primary objective of this investigation was to evaluate & compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.


Condition Intervention Phase
Knee Osteoarthritis
Device: PFC Sigma knee with all-poly tibial component
Device: PFC Sigma knee with metal backed tibia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparative evaluation of any post-operative variation between subjects receiving all-polyethylene and metal-backed tibia components in change from baseline at each post operative time points in terms of SF 12 and OKS [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: October 1999
Study Completion Date: March 2015
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 - All Polyethylene Tibia
Total knee replacement with an all polyethylene tibial tray
Device: PFC Sigma knee with all-poly tibial component
Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
Active Comparator: 2 - Poly & Metal Tibia
Total knee replacement with a metal-backed tibial component
Device: PFC Sigma knee with metal backed tibia
Orthopaedic implant for total knee replacement with a metal-backed tibial component

Detailed Description:

Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components.

The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects requiring a primary knee replacement.
  • Subjects aged 65 years or more.
  • Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
  • Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.

Exclusion Criteria:

  • Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
  • Subjects who have had a renal transplant.
  • Subjects with a metabolic bone disorder.
  • Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
  • Subjects whose contralateral knee is already included in this study.
  • Subjects who have a history of active joint sepsis.
  • Subjects who have a recent history of high dose systemic corticosteroids.
  • Subjects with psycho-social disorders or physical disabilities that would limit rehabilitation.
  • Subjects requiring a bone graft.
  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: NCT00733928

Locations
United Kingdom
Department of Orthopaedics, Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
DePuy International
  More Information

Publications:
Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733928     History of Changes
Other Study ID Numbers: CT 99/26 
Study First Received: August 11, 2008
Last Updated: May 27, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Arthroplasty,
Replacement,
Knee,
P.F.C.
Sigma
all-polyethylene

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

ClinicalTrials.gov processed this record on December 06, 2016