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Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00664989
Collaborator
University of Calgary (Other)
1
Enrollment
1
Location
20
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hypothesis: What is the difference in disease specific quality of life between patients who receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed hemiarthroplasty

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this multi-centered, randomized, controlled trial will be to determine if patient self-assessed outcomes (Western Ontario Osteoarthritis of Shoulder Score- WOOS) following humeral resurfacing are superior to those following a conventional, modular, stemmed, humeral prosthesis. The first phase of this study will be a one year pilot recruitment period. This is necessary in order to determine both a center by center, and national recruitment rate, and to determine a sample size necessary for a sufficiently powered full randomized trial. If a full randomized trial is not considered feasible following Phase 1, then a prospective cohort study will be completed.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty
    Actual Study Start Date :
    Aug 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2009
    Actual Study Completion Date :
    Apr 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Recent humeral resurfacing

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 OHRI Ottawa Ontario Canada K1Y4E9

      Sponsors and Collaborators

      • Ottawa Hospital Research Institute
      • University of Calgary

      Investigators

      • Principal Investigator: Peter Lapner, MD, OHRI

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Ottawa Hospital Research Institute
      ClinicalTrials.gov Identifier:
      NCT00664989
      Other Study ID Numbers:
      • 2006867-01H
      First Posted:
      Apr 23, 2008
      Last Update Posted:
      Mar 3, 2021
      Last Verified:
      Mar 1, 2021
      Studies a U.S. FDA-regulated Drug Product:
      No
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Ottawa Hospital Research Institute
      Hemiarthroplasty Stemmed Resurfacing Conventional Shoulder
      Additional relevant MeSH terms:
      Osteoarthritis

      Study Results

      No Results Posted as of Mar 3, 2021