About this trial
The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 to 95 years old
Undergoing reverse shoulder arthroplasty for any indication including revision surgery
Disqualifiers
Irreparable Subscapularis Tendon
Any history of proximal humerus fracture
Any revision with proximal humerus bone loss
Trial design
Parallel
Treatments tested in this trial
Subscap Tenotomy
Procedure/SurgeryGroup will not have their subscapularis tendon repaired following a reverse shoulder replacement.
Subscap Repair
Procedure/SurgeryGroup will have their subscapularis tendon repaired following a reverse shoulder replacement.
Treatment groups
Trial outcomes
Primary outcomes
Change in Internal Rotation
Internal rotation behind the back
Change in BOSS Scores
Change in Baltimore Orthopaedic Subscapularis Score (BOSS) over 2 years. The score asks enrolled patients a series of questions. The answer choices are the following: No difficulty, mild difficulty, severe difficulty, unable to perform.
Secondary outcomes
Change in ASES score
Change in American Shoulder and Elbow Surgeon (ASES) score over 2 years postoperatively compared to preoperative. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain possible.
Other outcomes
Ultrasound Evaluation
Blinded ultrasound evaluation of subscapularis integrity at 6 months. The "Sugaya classification" will be used to assess the subscapularis integrity. The score ranges from Type 1 to Type 5. Type 1: indicating sufficient thickness with homogeneously low intensity Type 2: sufficient thickness with partial high intensity Type 3: insufficient thickness without discontinuity Type 4: the presence of a minor discontinuity Type 5: the presence of a major discontinuity
Sponsors and contacts
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