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

Sponsor
Istituto Ortopedico Rizzoli
Study ID
NCT05855759
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Acellular Dermal Matrix — OTHER
    Patinets will be treated with acellular dermal matrix with standard arthroscopic technique performed as per normal clinical practice. For the tendon repair the acellular dermal matrix patch will be placed over the repaired tendon with dedicated sutures and anchors.
  • Acellular Dermal Matrix with autologous orthobiologics — OTHER
    Patinets will be treated with acellular dermal matrix enriched with autologous humeral bone marrow concentrate and subacromial bursa with standard arthroscopic technique. Humeral bone marrow concentrate will be harvested from the proximal humeral head inthe operating room and concentrated by an automatic close system.

Study Details

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.

Key Dates

First listed
May 11, 2023
Start date
Dec 18, 2023
Status verified
Feb 2026
Primary completion
Jul 30, 2025
Completion
May 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Acellular Dermal Matrix
    Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix
  • Experimental: Acellular Dermal Matrix with autologous orthobiologics
    Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix with orthobiologics autologous: humeral bone marrow concentrate and subacromial bursa

Primary Outcome Measure

re-tear rate [ Time Frame: 12 months after surgery ]

Central Contacts

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