RecruitingNot ApplicableNCT05855759

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

Acellular Matrix Homologous From Human Dermis in Combination With Orthobiologic Stimuli,Subacromial Bursa and Humeral Bone Marrow Concentrate, for Augmentation of Massiverotator Cuff Tears: Therapeutic Efficacy and Improvements for the Development of a Costeffective and Ready to Use Product

Sponsor

Istituto Ortopedico Rizzoli

Enrollment

72 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Rotator Cuff Tears

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

patients affected by large to massive lesion according to Gerber involving supraspinatus and infraspinatus tendons
tendon retraction \<=3 according to Thomazeau
fatty degeneration \<=3 according to Goutallier
possibility to obtain tendon reduction,
pre-operative Magnetic Resonance Imaging,
ability to read, understand and complete outcome scores

Exclusion Criteria11

patients affected by osteoarthritic degeneration,
frozen shoulder,
symptomatic acromioclavicular arthritis,
revision surgeries,
inability to cope with post-operative rehabilitation regimen,
autoimmune connective tissue disease,
current or past hematologicaldisorders,
comorbidities affecting healing,
active infections,
cancers,
pregnancy and lactation

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Interventions

OTHERAcellular 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.

OTHERAcellular 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.