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Sponsors and Collaborators: |
Ottawa Health Research Institute University of Calgary |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00664989 |
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 |
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Osteoarthritis |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty |
Estimated Enrollment: | 75 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
recent humeral resurfacing
Inclusion Criteria:
Responsible Party: | OHRI ( Peter Lapner ) |
Study ID Numbers: | 2006867-01H |
Study First Received: | April 21, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00664989 |
Health Authority: | Canada: Health Canada |
Hemiarthroplasty Stemmed Resurfacing Conventional Shoulder |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |