Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Not Applicable

Completed

• Conditions: Morselized Osteotomy; Subscapularis Peel
• Interventions: Procedure: subscapularis peel; Procedure: osteotomy

• Registration Number: NCT00508105
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.

Detailed Description

The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2017-05-29
• Results First Submitted QC: 2020-03-25
• Status Verified: 2020-04
• Results First Posted: 2020-04-07
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.

Exclusion Criteria

• Active joint or systemic infection
• Significant muscle paralysis
• Rotator cuff tear arthroplasty
• Major medical illness
• Unable to speak or read English/French
• Psychiatric illness that precludes informed consent
• Unwilling to be followed for 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subscapularis peel	subscapularis peel	-
osteotomy	osteotomy	-

Primary Outcome Measures

Name	Time	Method
Subscapularis Strength	2 years	Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force.

Secondary Outcome Measures

Name	Time	Method
Western Ontario Osteoarthritis of the Shoulder Index	2 Years	The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
American Shoulder and Elbow Score	2 Years	The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.

Trial Locations

Locations (1)

The Ottawa Hosptial; 🇨🇦 Ottawa, Ontario, Canada