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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: Acellular Dermal Matrix
* Other: Acellular Dermal Matrix with autologous orthobiologics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acellular Dermal Matrix<br>Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix | Other: Acellular Dermal Matrix<br>* 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.<br>|
| Experimental: Acellular Dermal Matrix with autologous orthobiologics<br>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 | Other: Acellular Dermal Matrix with autologous orthobiologics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-tear rate | Presence/absence of re-tear on magnetic resonance imaging | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cell yeld | number of stromals cells contained in the humeral bone marrow concentrate | baseline | 
| subacromial bursa | Half of the subacromial bursal tissue wll be assessed for determining the cell yield (number of stromal cells contained for mg of tissue) and half for histological processing | baseline |