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

Rotator Cuff Tears Clinical Trial

— MODA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855759
• Other study ID #: MODA
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Marco Cavallo, MD
• Phone: 0039.051.63.66
• Email: marco.cavallo[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 30, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 20 — View Citation

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	re-tear rate	Presence/absence of re-tear on magnetic resonance imaging	12 months after surgery
Secondary	cell yeld	number of stromals cells contained in the humeral bone marrow concentrate	baseline
Secondary	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	baseline