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

NCT03488433 | Withdrawn DMC FDA Device

• 1 other identifier: STUDY00008723
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear Arthropathy; Rotator Cuff Tear

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at 6 weeks, 12 weeks, 5 months, and 12 months following the index procedure.

Secondary Outcomes (6)

• Visual analog scale (VAS) pain score

  Measured at 6 weeks, 12 weeks, and 5 months, and 12 months after surgery

• American Shoulder and Elbow Surgeons (ASES) score

  Assessed at 5 and 12 months after surgery

• Patient compliance 5-point Likert-type scale

  Assessed at 12 weeks after surgery

• Patient satisfaction 5-point Likert-type scale

  Measured at 12 weeks

• Complications

  Assessed at 12 months after surgery

Study Arms (2)

Antirotation sling

ACTIVE COMPARATOR

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

Device: Antirotation sling

abduction brace

ACTIVE COMPARATOR

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

Device: Abduction brace

Interventions

Abduction brace DEVICE

Donjoy Ultrasling IV

abduction brace

Antirotation sling DEVICE

Donjoy shoulder immobilizer

Antirotation sling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (9)

• 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.

  PMID: 25213827 BACKGROUND

• 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.

  PMID: 26189808 BACKGROUND

• 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.

  PMID: 28427872 BACKGROUND

• 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.

  PMID: 1670437 BACKGROUND

• 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.

  PMID: 25957544 BACKGROUND

• 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.

  PMID: 23352183 BACKGROUND

• 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.

  PMID: 21628648 BACKGROUND

• 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.

  PMID: 11734494 BACKGROUND

• 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.

  PMID: 24806015 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: April 5, 2018
• Study Start: November 1, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)