Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/10/2019 |
| Start Date: | March 1, 2019 |
| End Date: | November 1, 2020 |
| Contact: | Christopher A Kowalski, MD |
| Email: | ckowalski@pennstatehealth.psu.edu |
| Phone: | 8018843378 |
Randomized Controlled Trial Comparing Abduction Shoulder Brace Versus Antirotation Sling for Postoperative Immobilization Following Reverse Total Shoulder Arthroplasty and Rotator Cuff Repair
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.
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.
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.
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
We found this trial at
1
site
Hershey, Pennsylvania 17033
Principal Investigator: Christopher Kowalski, MD
Phone: 801-884-3378
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