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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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 criteria

Qualifiers

Age range: ≥18 years

Irreparable rotator cuff tear suspected on pre-operative MRI

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Superior Capusular Reconstruction
  • Partial Rotator Cuff Repair

Treatment groups

105 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospitals Cleveland Medical Center

Lead sponsor

Lake Health

Collaborator

Midwest Orthopaedics at Rush

Collaborator