Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

NCT ID: NCT00664989

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Recent humeral resurfacing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Lapner, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

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OHRI

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2006867-01H

Identifier Type: -

Identifier Source: org_study_id

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