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Bioinductive Patch for Full-Thickness Rotator Cuff Tears

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Dec 1, 2026 to Jul 1, 2028
    • Study completion date: Dec 1, 2027 to Jul 1, 2029
    v6
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 1, 2027
    • Site contact updated
    v5
  3. Interventions: Regeneten bioinductive implant (Biological), Ultrasound Imaging (Diagnostic Test), arthroscopic rotator cuff repair (Procedure) to Bioinductive implant (Biological), Ultrasound Imaging (Diagnostic Test), arthroscopic rotator cuff repair (Procedure)
    • Collaborators shortened, about 4 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 30, 2022 to Aug 16, 2022
    • Site details revised
    v3
  5. Start date: Jul 1, 2022 to Jul 30, 2022v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.
Trial Details
NCT Number NCT05439850
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
Related terms Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov