RecruitingNot ApplicableNCT04742452

Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears


Sponsor

University Hospitals Cleveland Medical Center

Enrollment

105 participants

Start Date

Nov 24, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria2

  • Age range: ≥18 years
  • Irreparable rotator cuff tear suspected on pre-operative MRI

Exclusion Criteria9

  • 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
  • Irreparable subscapularis muscle intraoperatively
  • Active infection within the ipsilateral glenohumeral joint
  • Neurologic pathology limiting shoulder function
  • Current smoker
  • Workers' compensation claim

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Interventions

PROCEDURESuperior Capusular Reconstruction

Superior 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.

PROCEDUREPartial Rotator Cuff Repair

Partial 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.


Locations(3)

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Lake Health

Willoughby, Ohio, United States

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NCT04742452


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