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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.
Full description
Rotator cuff injury is a commonly encountered problem within the United States. In most cases, surgical repair can reduce pain and restore baseline functional status. However, in the case of an irreparable rotator cuff tear, management becomes more challenging as these injuries tend to be larger in size, are inelastic secondary to tendon retraction, and exhibit fatty infiltration and rotator cuff atrophy1. A multitude of surgical approaches for an irreparable rotator cuff tear have been described in the literature, including partial repair alone, partial repair with superior capsular reconstruction (SCR), arthroscopic debridement, graft interposition, balloon spacer arthroplasty, tendon transfers, and reverse total shoulder arthroplasty (rTSA)2. In younger patients, the traditional approach to managing these injuries involved partial rotator cuff repair with subacromial decompression and debridement with the hopes of providing the patient with some restoration of function and pain relief3,4. Clinical studies have demonstrated that partial repair can lead to an improvement in pain and function in the early post-operative period; long-term outcomes following this procedure were less reliable3. In addition, a high rate of failure has been associated with partial rotator cuff repair alone. Partial repair with SCR is a relatively new surgical procedure that has become an increasingly popular treatment modality in recent years because of early promising biomechanical and functional outcomes5,6. However, there have been no prospective randomized assessments of SCR. Therefore, the long-term outcomes of SCR compared to the standard of care, namely partial rotator cuff repair, are unknown.
This will be a multi-center, prospective randomized controlled trial. Prior to enrollment, patients will be screened for inclusion criteria. Participants who meet the eligibility criteria and are suspected to have an irreparable rotator cuff tear will be randomized into one of the two treatment arms prior to surgery. Group 1 will receive partial rotator cuff repair alone while group 2 will receive partial rotator cuff repair with SCR. All patients with suspected irreparable rotator cuff tears will be consented in clinic. There is the potential situation where the surgeon believed that the rotator cuff tear was irreparable based on clinical and radiographic evidence but was able to completely repair the tear intraoperatively. Based on the modified intention-to-treat (mITT) principle, these select patients will be dropped from the study and will no longer be followed for research purposes. Randomization will occur with a stratified randomization excel spreadsheet. Each group will be followed post-operatively for 24 months. The primary objective of this study is to compare pain and functional outcomes between the two treatment arms. The secondary objective is to assess the failure rate between the two treatment arms.
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105 participants in 2 patient groups, including a placebo group
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John T Strony, BS
Data sourced from clinicaltrials.gov
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