About this trial
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 criteria
Qualifiers
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,
Disqualifiers
patients affected by osteoarthritic degeneration,
frozen shoulder,
symptomatic acromioclavicular arthritis,
revision surgeries,
Trial design
Treatments tested in this trial
- Acellular Dermal Matrix
- Acellular Dermal Matrix with autologous orthobiologics