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NCT Number: NCT05855759

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

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.

Recruiting

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. re-tear rate

    Time frame: 12 months after surgery

    Presence/absence of re-tear on magnetic resonance imaging

Secondary outcomes

  1. cell yeld

    Time frame: baseline

    number of stromals cells contained in the humeral bone marrow concentrate

  2. subacromial bursa

    Time frame: baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Cavallo, MD

CONTACT

[email protected]

0039.051.63.66 ext. 927

Matilde Tschon, BSC

CONTACT

[email protected]

0039051.63.66 ext. 472

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: MODA

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 11, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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