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โ† Trials
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Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears

RecruitingNAAges 18 Years - 65 YearsAllIstituto Ortopedico Rizzoli
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Acellular Dermal Matrix
  • Acellular Dermal Matrix with autologous orthobiologics
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Where

1 site
Istituto Ortopedico Rizzoli
Bologna, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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