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Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 24, 2025 (before its estimated September 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Mar 2024); last known: Recruiting
  2. Study sites: 3 to 4v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 15, 2023 to Sep 25, 2023
    v3
  4. Primary completion date: Sep 1, 2025 to Sep 15, 2025
    • Study completion date: Sep 1, 2026 to Sep 15, 2026
    • Start date: Sep 1, 2023 to Sep 15, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05981833
Lead Sponsor Arthrex, Inc.
Conditions
(from sponsor)		 Full-thickness Rotator Cuff Tear
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov