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

Primary Purpose

Rotator Cuff Tears

Status

Not yet recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Acellular Dermal Matrix

Acellular Dermal Matrix with autologous orthobiologics

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Acellular Dermal Matrix

Acellular Dermal Matrix with autologous orthobiologics

Arm Description

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

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

Outcomes

Primary Outcome Measures

re-tear rate

Presence/absence of re-tear on magnetic resonance imaging

Secondary Outcome Measures

cell yeld

number of stromals cells contained in the humeral bone marrow concentrate

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

Full Information

NCT ID

NCT05855759

First Posted

April 14, 2023

Last Updated

October 3, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT05855759

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 15, 2023 (Anticipated)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acellular Dermal Matrix

Arm Type

Active Comparator

Arm Description

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

Arm Title

Acellular Dermal Matrix with autologous orthobiologics

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Acellular Dermal Matrix

Intervention Description

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

Intervention Name(s)

Acellular Dermal Matrix with autologous orthobiologics

Intervention Description

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.

Primary Outcome Measure Information:

Title

re-tear rate

Description

Presence/absence of re-tear on magnetic resonance imaging

Time Frame

12 months after surgery

Secondary Outcome Measure Information:

Title

cell yeld

Description

number of stromals cells contained in the humeral bone marrow concentrate

Time Frame

baseline

Title

subacromial bursa

Description

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

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco Cavallo, MD

Phone

0039.051.63.66

Ext

927

marco.cavallo@ior.it

First Name & Middle Initial & Last Name or Official Title & Degree

Matilde Tschon, BSC

Phone

0039051.63.66

Ext

472

matilde.tschon@ior.it

Facility Information:

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

State/Province

ZIP/Postal Code

40136

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

21691735

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. 2011 Jul;95 Suppl 1:S13-23. doi: 10.1007/s12306-011-0141-8.

Results Reference

result

PubMed Identifier

22689414

Citation

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.

Results Reference

result

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

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