Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

This study is currently recruiting participants.

Verified by Ottawa Health Research Institute, April 2008

Sponsors and Collaborators:	Ottawa Health Research Institute University of Calgary
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00664989

Purpose

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
Osteoarthritis

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty

Further study details as provided by Ottawa Health Research Institute:

Biospecimen Retention: None Retained

Biospecimen Description:

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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

recent humeral resurfacing

Criteria

Inclusion Criteria:

Recent humeral resurfacing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664989

Contacts

Contact: Peter Lapner, MD

(613) 737-8377

Locations

Canada, Ontario
OHRI	Recruiting
Ottawa, Ontario, Canada, K1Y4E9

Sponsors and Collaborators

Ottawa Health Research Institute

University of Calgary

More Information

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

Keywords provided by Ottawa Health Research Institute:

Hemiarthroplasty Stemmed Resurfacing Conventional Shoulder

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009