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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT04742452
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Superior Capusular Reconstruction — PROCEDURE
    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.
  • Partial Rotator Cuff Repair — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Nov 24, 2020
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Superior Capsular Reconstruction
  • Placebo Comparator: Partial Rotator Cuff Repair

Primary Outcome Measure

Pain Visual Analog Scale (VAS) [ Time Frame: 6 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Midwest Orthopaedics at RushChicagoIllinois60612
Grant Garrigues, MD
University Hospitals Cleveland Medical CenterClevelandOhio44106
John Strony, BS
[email protected]
908-268-3663
Robert Gillespie, MD (PRINCIPAL_INVESTIGATOR)
Lake HealthWilloughbyOhio44094
Eric Parsons, MD

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By research site
Midwest Orthopaedics at Rush· Chicago, ILUniversity Hospitals Cleveland Medical Center· Cleveland, OHLake Health· Willoughby, OH

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