Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acellular Dermal Matrix, Acellular Dermal Matrix with autologous orthobiologics.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acellular Matrix Homologous From Human Dermis in Combination With Orthobiologic Stimuli,Subacromial Bursa and Humeral Bone Marrow Concentrate, for Augmentation of Massiverotator Cuff Tears: Therapeutic Efficacy and Improvements for the Development of a Costeffective and Ready to Use Product
Overview
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.
Interventions
- Other Acellular Dermal Matrix
Patinets will be treated with acellular dermal matrix with standard arthroscopic technique performed as per normal clinical practice. For the tendon repair the acellular dermal matrix patch will be placed over the repaired tendon with dedicated sutures and anchors. - Other Acellular Dermal Matrix with autologous orthobiologics
Patinets will be treated with acellular dermal matrix enriched with autologous humeral bone marrow concentrate and subacromial bursa with standard arthroscopic technique. Humeral bone marrow concentrate will be harvested from the proximal humeral head inthe operating room and concentrated by an automatic close system.
Primary outcome measures
- re-tear rate [Time frame: 12 months after surgery]
Secondary outcome measures (2)
- cell yeld [Time frame: baseline]
- subacromial bursa [Time frame: baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Publications
- Rotini R, Marinelli A, Guerra E, Bettelli G, Castagna A, Fini M, Bondioli E, Busacca M. Human dermal matrix scaffold augmentation for large and massive rotator cuff repairs: preliminary clinical and MRI results at 1-year follow-up. Musculoskelet Surg. 2011 Jul;95 Suppl 1:S13-23. doi: 10.1007/s12306-011-0141-8. PMID 21691735
- Bondioli E, Fini M, Veronesi F, Giavaresi G, Tschon M, Cenacchi G, Cerasoli S, Giardino R, Melandri D. Development and evaluation of a decellularized membrane from human dermis. J Tissue Eng Regen Med. 2014 Apr;8(4):325-36. doi: 10.1002/term.1530. Epub 2012 Jun 11. PMID 22689414
- Cavallo M, Solaro L, Tortorella F, Brunello V, Melandri D, Pagani S, Martini L, Guerra E, Tschon M. Acellular dermal matrix alone or in combination with subacromial bursa and humeral bone marrow concentrate for augmentation of massive rotator cuff tear repair: a double-blind randomized controlled trial protocol (MODA). Front Med (Lausanne). 2026 Mar 6;13:1724038. doi: 10.3389/fmed.2026.1724038. eC PMID 41868235
Identifiers
NCT: NCT05855759 · MODA