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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:
DePuy International
ClinicalTrials.gov Identifier:
NCT00733928
First received: August 11, 2008
Last updated: February 15, 2010
Last verified: February 2010
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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: 2 years ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: October 1999
Study Completion Date: January 2006
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - all poly 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
Experimental: 2 - metal backed
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.

Secondary endpoints: 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 Oxford Knee Score (OKS)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 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 who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  • Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.

Exclusion Criteria:

  • 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.
  • Female subjects who are pregnant or lactating.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).
  • Subjects who are currently involved in any injury litigation claims.
  • Subjects with a known history of poor compliance to medical treatment.
  • Subjects who have previously had an osteotomy or significant surgery in the affected knee.
  Contacts and Locations
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
Investigators
Principal Investigator: A W McCaskie, FRCS Freeman Hospital, Newcastle Upon Tyne
  More Information

Publications:

Responsible Party: Mick Borroff, DePuy International (see above)
ClinicalTrials.gov Identifier: NCT00733928     History of Changes
Other Study ID Numbers: CT 99/26
Study First Received: August 11, 2008
Last Updated: February 15, 2010
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 June 18, 2013