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

August 11, 2008
May 27, 2016
October 1999
May 2005   (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: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]
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 ]
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.

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.

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
  • 1 - All Polyethylene Tibia
    Total knee replacement with an all polyethylene tibial tray
    Intervention: Device: PFC Sigma knee with all-poly tibial component
  • Active Comparator: 2 - Poly & Metal Tibia
    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
67
March 2015
May 2005   (final data collection date for primary outcome measure)

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.
Both
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00733928
CT 99/26
No
Not Provided
Not Provided
DePuy International
DePuy International
Not Provided
Not Provided
DePuy International
May 2016

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