Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Study Overview
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Brief Summary
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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
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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 ?

Official Title
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Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Conditions
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Subscapularis Peel, Morselized Osteotomy

Intervention / Treatment
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* Procedure: subscapularis peel
* Procedure: osteotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: subscapularis peel<br> | Procedure: subscapularis peel<br>* Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel.<br>* Other names: non applicable;|
| Active Comparator: osteotomy<br> | Procedure: osteotomy<br>* This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.<br>* Other names: non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subscapularis Strength | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Osteoarthritis of the Shoulder Index | 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. | 2 Years | 
| American Shoulder and Elbow Score | 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. | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Shoulder, subscapularis peel, osteotomy