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

August 11, 2008
February 15, 2010
October 1999
November 2004   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00733928 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly
Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.

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.

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)

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Device: PFC Sigma knee with all-poly tibial component
    Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
  • Device: PFC Sigma knee with metal backed tibia
    Orthopaedic implant for total knee replacement with a metal-backed tibial component
  • Experimental: 1 - all poly tibia
    Total knee replacement with an all polyethylene tibial tray
    Intervention: Device: PFC Sigma knee with all-poly tibial component
  • Experimental: 2 - metal backed
    Total knee replacement with a metal-backed tibial component
    Intervention: Device: PFC Sigma knee with metal backed tibia
Muller SD, Deehan DJ, Holland JP, Outterside SE, Kirk LM, Gregg PJ, McCaskie AW. Should we reconsider all-polyethylene tibial implants in total knee replacement? J Bone Joint Surg Br. 2006 Dec;88(12):1596-602.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
January 2006
November 2004   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00733928
CT 99/26
No
Mick Borroff, DePuy International (see above)
DePuy International
Not Provided
Principal Investigator: A W McCaskie, FRCS Freeman Hospital, Newcastle Upon Tyne
DePuy International
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP