An interventional study of Abduction brace and Antirotation sling in Rotator Cuff Tear Arthropathy and Rotator Cuff Tear, sponsored by Milton S. Hershey Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment
Among 19 studies in Rotator Cuff Tear Arthropathy with a site in United States — 5 open to participants now, 7 under way, none of them phase 3. Rotator Cuff Tear Arthropathy · United States.
Among the 19 studies in Rotator Cuff Tear Arthropathy with a site in United States, this one is the 11th largest by enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2019, is one of 11 with no phase, and was the 6th registered.
57 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
Browse Rotator Cuff Tear Arthropathy studies →5 of the 19 studies in Rotator Cuff Tear Arthropathy with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 18+
Arthrex, Inc. · Sites in United States
Ages 18–100
Henry Ford Health System · Sites in United States
Ages 18+
Stryker Trauma and Extremities · Sites in United States, Canada, France and 2 more countries
Ages 18+
Exactech · Sites in United States, Canada, France and 3 more countries
Ages 21+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Rotator Cuff Tear Arthropathy studies recruiting now, 6 (50%) set no upper age limit and 2 (17%) stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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19 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2019.
Median enrollment 94 across the 12 interventional studies, 160 across the 7 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
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4 of 19 have an industry lead sponsor. The 10 most frequent:
Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
Milton S. Hershey Medical Center has 1 study filed under Rotator Cuff Tear Arthropathy — fewer than ten, so there is no comparison to draw.
1 of the studies in Rotator Cuff Tear Arthropathy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03409718Zimmer BiometDatabase Retrieval for the Comprehensive Shoulder | 2026-12 |
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Among the 19 studies in Rotator Cuff Tear Arthropathy with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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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:
arthroplasty for fracture, revision surgery, insufficient bone stock requiring hemiarthroplasty, deltoid dysfunction, history of rheumatoid arthritis.
Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
Device: Antirotation sling
Patients who undergo reverse shoulder arthroplasty or rotator cuff repair will be randomly assigned to this group.
Device: Abduction brace
Donjoy Ultrasling IV
Donjoy shoulder immobilizer
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.
Time frame: Measured at 6 weeks, 12 weeks, 5 months, and 12 months following the index procedure.
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
Time frame: Measured at 6 weeks, 12 weeks, and 5 months, and 12 months after surgery
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
Time frame: Assessed at 5 and 12 months after surgery
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)
Time frame: Assessed at 12 weeks after surgery
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)
Time frame: Measured at 12 weeks
Complications
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
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)
Time frame: Assessed at 5 and 12 months after surgery
Plan to share: No
Ran from Nov 2019 to primary completion in Dec 2019, 1 month.
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This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Rotator Cuff Tear Arthropathy →
Milton S. Hershey Medical Center →