Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
Recruiting now · Not applicable
Conditions studied: Rotator Cuff Tears
In brief
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.
Key facts
- Study ID
- NCT05855759
- Run by
- Istituto Ortopedico Rizzoli
- People needed
- 72
- Starts
- 2023-12-18
- Expected to finish
- 2026-05-30
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Istituto Ortopedico Rizzoli — Bologna, BO, Italy (enrolling)
Full record on ClinicalTrials.gov
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