Using acellular dermal matrix to enhance repair of massive rotator cuff tears
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
Run by Istituto Ortopedico Rizzoli · NCT05855759 · Data updated 2026-11-12
This study is testing if using a special skin-based material during surgery can help people with large rotator cuff tears heal better and recover faster.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | December 18, 2023 |
| Main results expected | July 30, 2025 |
| Study ends | May 30, 2026 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT05855759 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with large to massive rotator cuff tears involving the supraspinatus and infraspinatus tendons, who meet specific criteria regarding tendon retraction and fatty degeneration.
✕Probably not a fit
Patients with osteoarthritic degeneration, frozen shoulder, or other significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of an acellular dermal matrix derived from human skin in combination with orthobiologic stimuli to improve surgical outcomes for patients with massive rotator cuff tears. The approach involves utilizing a patented method to create an acellular matrix that retains its biological and structural properties. The goal is to demonstrate the therapeutic efficacy of this technique in patients with significant rotator cuff injuries, potentially leading to better healing and recovery. Participants will undergo surgical repair augmented with this matrix and autologous orthobiologics.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing and functional outcomes for patients with massive rotator cuff tears.
How similar studies have gone: While the use of acellular dermal matrices has shown promise in limited cases, this specific combination approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Istituto Ortopedico Rizzoli
Bologna, Bo, Italy Recruiting
Study contacts
- Study coordinator: Marco Cavallo, MD
- Email: marco.cavallo@ior.it
- Phone: 0039.051.63.66
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
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We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.
-
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This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.