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

NCT ID: NCT05855759

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2026-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acellular Dermal Matrix

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

Group Type: ACTIVE_COMPARATOR

Acellular Dermal Matrix

Intervention Type: 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 with autologous orthobiologics

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

Group Type: EXPERIMENTAL

Acellular Dermal Matrix with autologous orthobiologics

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Cavallo, MD

Role: CONTACT

marco.cavallo@ior.it

0039.051.63.66 ext. 927

Matilde Tschon, BSC

Role: CONTACT

matilde.tschon@ior.it

0039051.63.66 ext. 472

References

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.

Reference Type: RESULT

PMID: 21691735 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22689414 (View on PubMed)

Other Identifiers

MODA

Identifier Type: -

Identifier Source: org_study_id