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

NCT05855759 | Recruiting

• 1 other identifier: MODA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• re-tear rate

  Presence/absence of re-tear on magnetic resonance imaging

  12 months after surgery

Secondary Outcomes (2)

• cell yeld

  baseline

• subacromial bursa

  baseline

Study Arms (2)

Acellular Dermal Matrix

ACTIVE COMPARATOR

Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix

Other: Acellular Dermal Matrix

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

Other: Acellular Dermal Matrix with autologous orthobiologics

Interventions

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.

Acellular Dermal Matrix with autologous orthobiologics

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.

Acellular Dermal Matrix

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 41868235 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Marco Cavallo, MD

CONTACT

0039.051.63.66; marco.cavallo@ior.it

Matilde Tschon, BSC

CONTACT

0039051.63.66; matilde.tschon@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 11, 2023
• Study Start: December 18, 2023
• Primary Completion: July 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

IT (1)