Acellular Matrix From Human Dermis Combined With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears: Evaluating Therapeutic Efficacy and Development of a Cost-Effective Product

What this Trial Is About

This research aims to evaluate the therapeutic effectiveness of using an acellular dermal matrix derived from human skin combined with autologous orthobiologics for patients with large to massive rotator cuff tears. The study focuses on patients with tears involving the supraspinatus and infraspinatus tendons, addressing a significant surgical challenge. The trial is sponsored by Istituto Ortopedico Rizzoli and involves a randomized, double-blind design to compare treatment methods. Participants will be randomly assigned to one of two groups: one group will receive a suture-bridge surgical repair augmented with the acellular dermal matrix alone, while the other group will receive the same surgical technique combined with orthobiologic treatments, including humeral bone marrow concentrate and subacromial bursa tissue. The orthobiologics are harvested and prepared during surgery using an automatic concentrating system. Both treatments use standard arthroscopic procedures with dedicated sutures and anchors. Throughout the study, participants will undergo pre-operative magnetic resonance imaging and complete outcome assessments. Researchers will monitor the re-tear rate of the rotator cuff at 12 months after surgery as the primary outcome. Secondary outcomes include cell yield and subacromial bursa assessments at baseline. The trial requires participants to be able to understand and complete outcome scores and involves follow-up to evaluate the healing and effectiveness of the treatments over time.

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