Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00664989
• Lead Sponsor: 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

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Recent humeral resurfacing

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

OHRI; 🇨🇦 Ottawa, Ontario, Canada