Clinical Trial: Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.

Brief Summary: This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.

Detailed Summary: The purpose of this study is to collect more information about the Sigma HP® Partial Knee System made by DePuy International. The aim of this study is to measure how this particular type of knee replacement performs over a two year period.
Sponsor: DePuy International

Current Primary Outcome: Survivorship (revision) [ Time Frame: 2 years ]

Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)


Original Primary Outcome: Survivorship (revision) [ Time Frame: 3 years ]

Kaplan Meier Survival analysis at 3 years (based on revision of the femoral or tibial components)


Current Secondary Outcome:

Original Secondary Outcome:

  • Survivorship [ Time Frame: 1, 2, 5 and 10 years ]
    Survival analyses at each post-operative assessment.
  • Knee Society Score [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment
  • KOOS [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • HAAS [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • Kujala Score [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • Oxford Knee Score [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • EQ-5D [ Time Frame: 1, 2, 5 and 10 years ]
    Mean change from baseline (pre-op) to each post-operative assessment.
  • Radiographic Analysis [ Time Frame: 1, 2, 5 and 10 years ]
    Change from 6 week post-operative assessment at all post-operative timepoints to identify the number of implants that are 'at risk'.


Information By: DePuy International

Dates:
Date Received: December 6, 2011
Date Started: January 2009
Date Completion:
Last Updated: May 27, 2016
Last Verified: June 2015