Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair
Withdrawn before enrolling · Not applicable
Conditions studied: Rotator Cuff Tear Arthropathy, Rotator Cuff Tear
In brief
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.
Key facts
- Study ID
- NCT03488433
- Run by
- Milton S. Hershey Medical Center
- People needed
- 0
- Starts
- 2019-11-01
- Expected to finish
- 2019-12-16
- Last updated by the study team
- 2019-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- University of Missouri — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
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