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

Overview

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 Title of Study: “Randomized Controlled Trial Comparing Abduction Shoulder Brace Versus Antirotation Sling for Postoperative Immobilization Following Reverse Total Shoulder Arthroplasty and Rotator Cuff Repair”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 16, 2019

Detailed 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.

Interventions

• Device: Abduction brace
  • Donjoy Ultrasling IV
• Device: Antirotation sling
  • Donjoy shoulder immobilizer

Arms, Groups and Cohorts

• Active Comparator: Antirotation sling
  • Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
• Active Comparator: abduction brace
  • Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.

Clinical Trial Outcome Measures

Primary Measures

• Postoperative range of motion
  • Time Frame: Measured at 6 weeks, 12 weeks, 5 months, and 12 months following the index procedure.
  • Both active and passive range of motion will be measured in forward elevation, external rotation at the side, internal rotation at extension, external rotation at abduction, and internal rotation at abduction by the examiners using a handheld goniometer. Multiple time points are for assessing the changes in motion.

Secondary Measures

• Visual analog scale (VAS) pain score
  • Time Frame: Measured at 6 weeks, 12 weeks, and 5 months, and 12 months after surgery
  • Measures subjective pain; minimum 0, maximum 10 with 0 being a pain-free condition and 10 being the worst pain ever experienced
• American Shoulder and Elbow Surgeons (ASES) score
  • Time Frame: Assessed at 5 and 12 months after surgery
  • Measures patient’s subjective shoulder function using a series of survey questions regarding subjective rating of range of motion, strength, use, and pain of the shoulder; minimum 0 to maximum 100 with 0 being the worst shoulder function and 100 being the best shoulder function
• Patient compliance 5-point Likert-type scale
  • Time Frame: Assessed at 12 weeks after surgery
  • Measure compliance with their assigned immobilization method measured using a 5-point Likert-type scale (Question: Did you wear the sling as instructed in the protocol? Not at all, occasionally, about a half of the time, for the most part, yes definitely)
• Patient satisfaction 5-point Likert-type scale
  • Time Frame: Measured at 12 weeks
  • Measures overall patient satisfaction with their immobilization method using a 5-point Likert-type scale (Question: Are you satisfied with the immobilization method using the sling you wore? Not at all, not much, so-so, pretty much, yes definitely)
• Complications
  • Time Frame: Assessed at 12 months after surgery
  • Such as shoulder dislocations, wound healing issue, pain development at areas other than the operated shoulder due to the immobilization, etc
• QuickDASH (Disability of arm, shoulder, and hand) score system
  • Time Frame: Assessed at 5 and 12 months after surgery
  • Measures the extent of subjective disability of upper extremity; consisted of survey questions regarding subjective pain and function of the upper extremity; Minimum 0, maximum 100 with 0 being no disability and 100 being most severe disability)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Milton S. Hershey Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: H Mike Kim, Associate Professor – University of Missouri-Columbia

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