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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
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.
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.
Istituto Ortopedico Rizzoli
Bologna, BO, Italy
RECRUITINGre-tear rate
Presence/absence of re-tear on magnetic resonance imaging
Time frame: 12 months after surgery
cell yeld
number of stromals cells contained in the humeral bone marrow concentrate
Time frame: 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
Time frame: baseline
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