Clinical Trial: A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-centre, Randomised, Parallel Group, Controlled Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement

Brief Summary: This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.

Detailed Summary:
Sponsor: DePuy International

Current Primary Outcome: To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period. [ Time Frame: 2yrs post-surgery ]

Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason.


Original Primary Outcome:

Current Secondary Outcome:

  • Implant survivorship at 5 and 10 years. [ Time Frame: 5 & 10 year post-op ]
    This post market study was terminated early; therefore the 5 and 10 year data was not collected.
  • To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices. [ Time Frame: 3 Months post-op ]
    The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
  • To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 6 Months post-op ]
    The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
  • To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 12 months post-op ]
    The Harris Hip score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
  • To Compare Harris Hip scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 24 months post-op ]
    The Harris Hip Score is a 0-100 point score (where 100 indicates excellent hip condition) assessing pain, function, range of motion, and absence of deformity, of the affected hip.
  • To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 5 & 10 years post-op ]
    This post market study was terminated early; therefore the 5 and 10 year data was not collected
  • To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 3 months post-op ]
    The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
  • To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 6 months post-op ]
    The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
  • To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 12 months post-op ]
    The Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
  • To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 24 months post-op ]
    he Oxford Knee Score (OKS) is a 12 to 60 patient recorded outcome (PRO) score (where 12 indicates the best outcome) that evaluates pain and function of the affected hip.
  • To Compare Oxford Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 5& 10 years post-op ]
    This post market study was terminated early; therefore the 5 & 10 year data was not collected
  • Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 3 months post-op ]
    Width of lucency increases over time or expands lengthwise (into neighboring zones).
  • Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 6 months post-op ]
    Width of lucency increases over time or expands lengthwise (into neighboring zones).
  • Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 12 months post-op ]
    Width of lucency increases over time or expands lengthwise (into neighboring zones).
  • Progressive Radiolucent Zone(s) - Femur: To compare Progressive Radiolucent Zone(s) incidence between subjects receiving the European, Spotorno, and Zweymuller hip devices [ Time Frame: 24 months post-op ]
    Width of lucency increases over time or expands lengthwise (into neighboring zones).
  • Progressiv

    Original Secondary Outcome:

    Information By: DePuy International

    Dates:
    Date Received: September 13, 2005
    Date Started: February 2000
    Date Completion:
    Last Updated: October 6, 2016
    Last Verified: October 2016