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

Primary Purpose

Rotator Cuff Tear Arthropathy, Rotator Cuff Tear

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abduction brace
Antirotation sling
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear Arthropathy focused on measuring Postoperative shoulder immobilization, Reverse total shoulder arthroplasty, Neutral rotation shoulder brace, Antirotation sling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antirotation sling

abduction brace

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative range of motion
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 Outcome Measures

Visual analog scale (VAS) pain score
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
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
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
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
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
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)

Full Information

First Posted
December 21, 2017
Last Updated
December 17, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03488433
Brief Title
Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair
Official Title
Randomized Controlled Trial Comparing Abduction Shoulder Brace Versus Antirotation Sling for Postoperative Immobilization Following Reverse Total Shoulder Arthroplasty and Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI institutional transition prior to enrollment
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy, Rotator Cuff Tear
Keywords
Postoperative shoulder immobilization, Reverse total shoulder arthroplasty, Neutral rotation shoulder brace, Antirotation sling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients undergoing reverse total shoulder arthroplasty or rotator cuff repair will be randomly assigned to two groups of immobilization method groups, namely abduction brace group and antirotation sling group.
Masking
None (Open Label)
Masking Description
Patients will be randomly assigned to either neutral rotation brace, or antirotation sling following reverse total shoulder arthroplasty. The patients, PI and co-investigators all will be blinded to patient assignments until the day of surgery when an envelope with their assignments are given to surgeon at day of surgery.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antirotation sling
Arm Type
Active Comparator
Arm Description
Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
Arm Title
abduction brace
Arm Type
Active Comparator
Arm Description
Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
Intervention Type
Device
Intervention Name(s)
Abduction brace
Intervention Description
Donjoy Ultrasling IV
Intervention Type
Device
Intervention Name(s)
Antirotation sling
Intervention Description
Donjoy shoulder immobilizer
Primary Outcome Measure Information:
Title
Postoperative range of motion
Description
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.
Time Frame
Measured at 6 weeks, 12 weeks, 5 months, and 12 months following the index procedure.
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) pain score
Description
Measures subjective pain; minimum 0, maximum 10 with 0 being a pain-free condition and 10 being the worst pain ever experienced
Time Frame
Measured at 6 weeks, 12 weeks, and 5 months, and 12 months after surgery
Title
American Shoulder and Elbow Surgeons (ASES) score
Description
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
Time Frame
Assessed at 5 and 12 months after surgery
Title
Patient compliance 5-point Likert-type scale
Description
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)
Time Frame
Assessed at 12 weeks after surgery
Title
Patient satisfaction 5-point Likert-type scale
Description
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)
Time Frame
Measured at 12 weeks
Title
Complications
Description
Such as shoulder dislocations, wound healing issue, pain development at areas other than the operated shoulder due to the immobilization, etc
Time Frame
Assessed at 12 months after surgery
Title
QuickDASH (Disability of arm, shoulder, and hand) score system
Description
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)
Time Frame
Assessed at 5 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25213827
Citation
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Results Reference
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Results Reference
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Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair

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