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

NCT04742452 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears

Interventions

PROCEDURE

Superior 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.

PROCEDURE

Partial 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.

Sponsors & Collaborators

  • Lake Health

    collaborator UNKNOWN

  • Midwest Orthopaedics at Rush

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742452 on ClinicalTrials.gov