The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.
Age range: ≥18 years
Irreparable rotator cuff tear suspected on pre-operative MRI
Pregnant, illiterate, or non-English speaking individuals
Rotator cuff pathology amenable to a complete repair intraoperatively
Moderate to severe rotator cuff arthropathy (Hamada grade ≥3)
Presence of glenohumeral arthritis on radiographs
Parallel
Superior Capusular Reconstruction
Procedure/SurgerySuperior capsular reconstruction is one treatment option for massive and irreparable rotator cuff tears. The superior shoulder capsule, a thin membranous structure located on the inferior surface of the supraspinatus and infraspinatus muscles, is often torn in this type of rotator cuff tear. In superior capsular reconstruction, this structure is reconstructed with acellular dermal allograft.
Partial Rotator Cuff Repair
Procedure/SurgeryPartial rotator cuff repair can be performed, in conjunction with other procedures such as subacromial decompression and biceps tenodesis, when a rotator cuff tear is not amenable to a complete repair.
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Graft/repair integrity via magnetic resonance imaging
Assessing the integrity of the repair, either SCR or the partial repair, to see if it is still intact at 12 months post-operatively.
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University Hospitals Cleveland Medical Center
Lead sponsor
Lake Health
Collaborator
Midwest Orthopaedics at Rush
Collaborator
