Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Arthrex, Inc.
Study ID
NCT05981833
Status
Recruiting
Apply to this trial

Conditions

  • Full-thickness Rotator Cuff Tear

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Repair with DAA (dermal allograft augmentation) — DEVICE
    Patients undergo rotator cuff repair with dermal allograft augmentation.

Study Details

The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).

Key Dates

Start date
Sep 25, 2023
Status verified
Mar 2024
Primary completion
Sep 15, 2025
Completion
Sep 15, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Repair without DAA
    repaired without dermal allograft augmentation (DAA).

Primary Outcome Measure

The primary outcome measure is healing evaluation in MRI [ Time Frame: 26 Weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Arizona, Banner HealthScottsdaleArizona85006
Anup Shah, MD
Anup Shah, MD (PRINCIPAL_INVESTIGATOR)
Orthopaedic & Nuerosurgery SpecialistsGreenwichConnecticut06831
Paul Sethi, MD
2038691145
Paul Sethi, MD (PRINCIPAL_INVESTIGATOR)
Southern Oregon Orthopedics Research FoundationMedfordOregon97504
Patrick Denard
5416082595
Patrick Denard, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Orthopedic Foundation for Research Education and ResearchNashvilleTennessee37204
Paul Brady
Paul Brady, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Arizona, Banner Health· Scottsdale, AZOrthopaedic & Nuerosurgery Specialists· Greenwich, CTSouthern Oregon Orthopedics Research Foundation· Medford, ORTennessee Orthopedic Foundation for Research Education and Research· Nashville, TN