Status:
RECRUITING
Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05855759
Start Date
December 18 2023
End Date
May 30 2026
Last Update
February 19 2026
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136