Rotator Cuff Tear Clinical Trial
Official title:
Randomized Controlled Trial Comparing Abduction Shoulder Brace Versus Antirotation Sling for Postoperative Immobilization Following Reverse Total Shoulder Arthroplasty and Rotator Cuff Repair
To compare the functional and anatomical outcomes, and patient satisfaction and compliance between two different postoperative immobilization methods - abduction shoulder brace versus simple arm sling - following 2 common shoulder surgical procedures - rotator cuff repair (RCR) and reverse total shoulder arthroplasty (RTSA) through a prospective randomized clinical trial.
Scientific Background and Gaps Rotator cuff repair and reverse total shoulder arthroplasty
are common procedures that aim to provide patients with less pain, better shoulder function,
and overall improved quality of life. The number of these procedures performed annually has
increased dramatically, and improved outcomes have been demonstrated for each intervention.
Part of the success of these operations is dependent on postoperative rehabilitation and
patient compliance. Shoulder immobilization versus early range of motion following each
procedure has conflicting data, and recent studies have shown that the method of shoulder
immobilization may not influence clinical outcomes. Previous studies, both clinical and
biomechanical, have demonstrated that arm position following RCR impacts tension and stress
placed on the repair, but few have shown whether this translates to improved patient
outcomes. Some surgeons prefer simple arm slings for the above-named procedures, while others
opt for the abduction brace. Multiple studies have shown the optimal shoulder position that
places the least amount of tension on the RCR, or soft tissue envelope following RTSA,
however there is no consensus as to the optimal postoperative immobilization technique that
significantly affects patient outcomes. An antirotation sling is significantly cheaper than
an abduction shoulder brace, and our anecdotal experience is that patients experience more
difficulties with an abduction shoulder brace than an antirotation sling. Our study aims to
determine whether patient outcomes are significantly affected by immobilization with an
abduction brace or simple arm sling. Our hypothesis is that antirotation slings are no better
or worse than shoulder abduction braces in regards to shoulder range of motion, satisfaction
and compliance with the immobilization method, and pain.
Study Rationale There is a lack of evidence regarding abduction braces versus simple arm
slings for postoperative immobilization following rotator cuff repair and reverse total
shoulder arthroplasty. A better understanding of outcomes between each device will allow for
more options available to the patient and surgeon, as well as a potential for decreased cost
to the patient as there is a substantial difference in cost between the two devices.
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