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

December 17, 2019 updated by: H Mike Kim, Milton S. Hershey Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antirotation sling
Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
Device: Antirotation sling
Donjoy shoulder immobilizer
Active Comparator: abduction brace
Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
Device: Abduction brace
Donjoy Ultrasling IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at 6 weeks, 12 weeks, 5 months, and 12 months following the index procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at 6 weeks, 12 weeks, and 5 months, and 12 months after surgery
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
Assessed at 5 and 12 months after surgery
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)
Assessed at 12 weeks after surgery
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)
Measured at 12 weeks
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
Assessed at 12 months after surgery
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)
Assessed at 5 and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

December 16, 2019

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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