Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Ottawa Hospital Research Institute87 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Subscapularis Peel Morselized Osteotomy

Interventions

subscapularis peelPROCEDURE

Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".

osteotomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ottawa Hosptial

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 2 Years

Data from ClinicalTrials.gov

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