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Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664989
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : March 3, 2021
University of Calgary
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

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.

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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 : August 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
recent humeral resurfacing

Inclusion Criteria:

  • Recent humeral resurfacing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664989

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Canada, Ontario
Ottawa, Ontario, Canada, K1Y4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
University of Calgary
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Principal Investigator: Peter Lapner, MD OHRI
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Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00664989    
Other Study ID Numbers: 2006867-01H
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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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:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases