RecruitingNot Applicable

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

Italy72 participantsStarted 2023-12-18

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

re-tear rate

Timeframe: 12 months after surgery

Trial details

NCT IDNCT05855759

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-30

Contact for this trial

Marco Cavallo, MD

0039.051.63.66 marco.cavallo@ior.it

View on ClinicalTrials.gov More Rotator Cuff Tears trials