Rotator Cuff Tears
Conditions
Brief 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.
Interventions
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.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| re-tear rate | 12 months after surgery | Presence/absence of re-tear on magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cell yeld | baseline | number of stromals cells contained in the humeral bone marrow concentrate |
| subacromial bursa | baseline | 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 |
Countries
Italy
Contacts
CONTACTMarco Cavallo, MD
CONTACTMatilde Tschon, BSC
Outcome results
None listed