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

NCT05855759 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Rotator Cuff Tears

Interventions

OTHER

Acellular Dermal Matrix

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.

OTHER

Acellular Dermal Matrix with autologous orthobiologics

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.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2025-07-30
Completion
2026-05-30

Countries

  • Italy

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 NCT05855759 on ClinicalTrials.gov