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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Other: Acellular Dermal Matrix; Other: Acellular Dermal Matrix with autologous orthobiologics

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Cavallo, MD; Phone Number: 927 0039.051.63.66; Email: marco.cavallo@ior.it
• Study Contact Backup: Name: Matilde Tschon, BSC; Phone Number: 472 0039051.63.66; Email: matilde.tschon@ior.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Recruiting
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acellular Dermal Matrix; Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix	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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-tear rate	Presence/absence of re-tear on magnetic resonance imaging	12 months after surgery

Secondary Outcome Measures

Outcome Measure	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	baseline

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: MODA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No