Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair

Penn State Health

Status: Withdrawn

Conditions: Rotator Cuff Tear; Rotator Cuff Tear Arthropathy

Treatments: Device: Abduction brace; Device: Antirotation sling

Study type: Interventional

Funder types: Other

Identifiers

NCT03488433

STUDY00008723

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients 18 years and above
• male or female Rotator cuff tear patients - adults with a small or medium-sized (less than 3 cm in the anteroposterior dimension) full-thickness tear of supraspinatus and/or infraspinatus tendon, diagnosed with MRI or ultrasound, unresponsive to conservative therapy for >3 months

Reverse total shoulder arthroplasty patients - adults with rotator cuff arthropathy, glenohumeral joint arthritis with significant glenoid wear or retroversion requiring reverse arthroplasty or massive irreparable rotator cuff tear, functional deltoid, as demonstrated on x-rays, MRI, and physical exam. Failed conservative management for >3 months

Exclusion criteria

• younger than 18 years old
• chronic opiate use, fibromyalgia
• Rotator cuff repair patients - no previous rotator cuff repair surgery, no concomitant preoperative stiffness (definition: < 30 degree passive external rotation, < 100 degree passive forward elevation), no concomitant full-thickness subscapularis tear, no neurologic disorder affecting the ipsilateral upper extremity, no concomitant cervical pathology, partial thickness tear, large or massive tears (>3cm in the anteroposterior dimension), glenohumeral or rotator cuff arthropathy, history of rheumatoid arthritis.
• Reverse total shoulder arthroplasty patients -no concomitant preoperative stiffness (definition: < 30 degree passive external rotation, < 100 degree passive forward elevation), no concomitant neurologic disorder affecting the ipsilateral upper extremity, no concomitant cervical pathology.

arthroplasty for fracture, revision surgery, insufficient bone stock requiring hemiarthroplasty, deltoid dysfunction, history of rheumatoid arthritis.

• prisoners
• non English speaking or unable to understand consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Antirotation sling

Active Comparator group

Description:

Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.

Treatment:

Device: Antirotation sling

abduction brace

Active Comparator group

Description:

Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.

Treatment:

Device: Abduction brace