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Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

NCT05981833 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-02-24

No results posted yet for this study

Summary

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).

Conditions

  • Full-thickness Rotator Cuff Tear

Interventions

DEVICE

Repair with DAA (dermal allograft augmentation)

Patients undergo rotator cuff repair with dermal allograft augmentation.

Sponsors & Collaborators

  • Arthrex, Inc.

    lead INDUSTRY

Principal Investigators

  • Alicia Ruiz, MS · Arthrex, Inc.

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2025-09-15
Completion
2026-09-15
FDA Device
Yes

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 NCT05981833 on ClinicalTrials.gov