Using acellular dermal matrix to enhance repair of massive rotator cuff tears
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT05855759 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with osteoarthritic degeneration, frozen shoulder, or other significant comorbidities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, BO
- Istituto Ortopedico Rizzoli — Bologna, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Marco Cavallo, MD
- Email: marco.cavallo@ior.it
- Phone: 0039.051.63.66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.