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

NCT ID: NCT03488433

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2019-12-16

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tear Arthropathy Rotator Cuff Tear

Keywords

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Postoperative shoulder immobilization Reverse total shoulder arthroplasty Neutral rotation shoulder brace Antirotation sling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Antirotation sling

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

Group Type ACTIVE_COMPARATOR

Antirotation sling

Intervention Type DEVICE

Donjoy shoulder immobilizer

abduction brace

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

Group Type ACTIVE_COMPARATOR

Abduction brace

Intervention Type DEVICE

Donjoy Ultrasling IV

Interventions

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Abduction brace

Donjoy Ultrasling IV

Intervention Type DEVICE

Antirotation sling

Donjoy shoulder immobilizer

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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H Mike Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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Kiet TK, Feeley BT, Naimark M, Gajiu T, Hall SL, Chung TT, Ma CB. Outcomes after shoulder replacement: comparison between reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Feb;24(2):179-85. doi: 10.1016/j.jse.2014.06.039. Epub 2014 Sep 9.

Reference Type BACKGROUND
PMID: 25213827 (View on PubMed)

Lambers Heerspink FO, van Raay JJ, Koorevaar RC, van Eerden PJ, Westerbeek RE, van 't Riet E, van den Akker-Scheek I, Diercks RL. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial. J Shoulder Elbow Surg. 2015 Aug;24(8):1274-81. doi: 10.1016/j.jse.2015.05.040.

Reference Type BACKGROUND
PMID: 26189808 (View on PubMed)

Hollman F, Wolterbeek N, Zijl JAC, van Egeraat SPM, Wessel RN. Abduction Brace Versus Antirotation Sling After Arthroscopic Cuff Repair: The Effects on Pain and Function. Arthroscopy. 2017 Sep;33(9):1618-1626. doi: 10.1016/j.arthro.2017.02.010. Epub 2017 Apr 17.

Reference Type BACKGROUND
PMID: 28427872 (View on PubMed)

Zuckerman JD, Leblanc JM, Choueka J, Kummer F. The effect of arm position and capsular release on rotator cuff repair. A biomechanical study. J Bone Joint Surg Br. 1991 May;73(3):402-5. doi: 10.1302/0301-620X.73B3.1670437.

Reference Type BACKGROUND
PMID: 1670437 (View on PubMed)

Conti M, Garofalo R, Castagna A. Does a brace influence clinical outcomes after arthroscopic rotator cuff repair? Musculoskelet Surg. 2015 Sep;99 Suppl 1:S31-5. doi: 10.1007/s12306-015-0357-0. Epub 2015 May 10.

Reference Type BACKGROUND
PMID: 25957544 (View on PubMed)

Jackson M, Tetreault P, Allard P, Begon M. Optimal shoulder immobilization postures following surgical repair of rotator cuff tears: a simulation analysis. J Shoulder Elbow Surg. 2013 Aug;22(8):1011-8. doi: 10.1016/j.jse.2012.10.042. Epub 2013 Jan 24.

Reference Type BACKGROUND
PMID: 23352183 (View on PubMed)

Pedowitz RA, Yamaguchi K, Ahmad CS, Burks RT, Flatow EL, Green A, Iannotti JP, Miller BS, Tashjian RZ, Watters WC 3rd, Weber K, Turkelson CM, Wies JL, Anderson S, St Andre J, Boyer K, Raymond L, Sluka P, McGowan R; American Academy of Orthopaedic Surgeons. Optimizing the management of rotator cuff problems. J Am Acad Orthop Surg. 2011 Jun;19(6):368-79. doi: 10.5435/00124635-201106000-00007.

Reference Type BACKGROUND
PMID: 21628648 (View on PubMed)

Hatakeyama Y, Itoi E, Pradhan RL, Urayama M, Sato K. Effect of arm elevation and rotation on the strain in the repaired rotator cuff tendon. A cadaveric study. Am J Sports Med. 2001 Nov-Dec;29(6):788-94. doi: 10.1177/03635465010290061901.

Reference Type BACKGROUND
PMID: 11734494 (View on PubMed)

Mall NA, Tanaka MJ, Choi LS, Paletta GA Jr. Factors affecting rotator cuff healing. J Bone Joint Surg Am. 2014 May 7;96(9):778-88. doi: 10.2106/JBJS.M.00583.

Reference Type BACKGROUND
PMID: 24806015 (View on PubMed)

Other Identifiers

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STUDY00008723

Identifier Type: -

Identifier Source: org_study_id