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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular Dermal Matrix | Active Comparator | Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix |
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| Acellular Dermal Matrix with autologous orthobiologics | Experimental | Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix with orthobiologics autologous: humeral bone marrow concentrate and subacromial bursa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular Dermal Matrix | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| re-tear rate | Presence/absence of re-tear on magnetic resonance imaging | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| cell yeld | number of stromals cells contained in the humeral bone marrow concentrate | baseline |
| subacromial bursa | Half of the subacromial bursal tissue wll be assessed for determining the cell yield (number of stromal cells contained for mg of tissue) and half for histological processing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Cavallo, MD | Contact | 0039.051.63.66 | 927 | marco.cavallo@ior.it |
| Matilde Tschon, BSC | Contact | 0039051.63.66 | 472 | matilde.tschon@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | BO | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21691735 | Result | 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. | |
| 22689414 | Result |
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|
| Acellular Dermal Matrix with autologous orthobiologics | Other | 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. |
|
| baseline |
| 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. |
| 41868235 | Derived | 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. eCollection 2026. |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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