Rotator Cuff Tear Clinical Trial
Official title:
Randomized Controlled Trial Comparing Abduction Shoulder Brace Versus Antirotation Sling for Postoperative Immobilization Following Reverse Total Shoulder Arthroplasty and Rotator Cuff Repair
Verified date | December 2019 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 16, 2019 |
Est. primary completion date | December 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Measured at 6 weeks, 12 weeks, and 5 months, and 12 months after surgery | |
Secondary | 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 | Assessed at 5 and 12 months after surgery | |
Secondary | 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) | Assessed at 12 weeks after surgery | |
Secondary | 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) | Measured at 12 weeks | |
Secondary | Complications | Such as shoulder dislocations, wound healing issue, pain development at areas other than the operated shoulder due to the immobilization, etc | Assessed at 12 months after surgery | |
Secondary | 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) | Assessed at 5 and 12 months after surgery |
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