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Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears

Study acronym: MODA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv10
  2. Minor Primary completion date: May 30, 2025 to Jul 30, 2025v9
  3. Minor Primary completion date: Apr 1, 2025 to May 30, 2025v8
  4. Notable Start date: Oct 15, 2023 to Dec 18, 2023
    • Primary completion date: Jan 1, 2025 to Apr 1, 2025
    v7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Sep 1, 2023 to Oct 15, 2023v5
  2. Notable Start date: Jun 1, 2023 to Sep 1, 2023
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  4. Notable Start date: May 2, 2023 to Jun 1, 2023v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 use of biologic acellular matrices for the surgical augmentation of rotator cuff lesions has greatly expanded inrecent years. The study team patented a method for removing cells from human dermis (Acellular Dermal Matrix), maintaining unaltered biological and structural integrity. Acellular Dermal Matrix has been succesfully used for rotator cuff surgical repair augmentation beside in a limited number of patients. The aim of the project is to demonstrate the therapeutical efficacy of this strategy in patients affected by rotator cuff massive tears. Acellular Dermal Matrix will be also combined with autologous orthobiologics.
Trial Details
NCT Number NCT05855759
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)
Rotator Cuff Tears
Related terms Rotator Cuff Injuries
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov