Actively Recruiting
Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-19
72
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 hematological disorders
- Comorbidities affecting healing
- Active infections
- Cancers
- Pregnancy and lactation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136
Actively Recruiting
Research Team
M
Marco Cavallo, MD
CONTACT
M
Matilde Tschon, BSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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