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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with large or massive rotator cuff tears, which are injuries to the shoulder that can cause pain and limit movement. The researchers are testing a special type of material called an Acellular Dermal Matrix, made from human skin, which is used during surgery to help repair these tears. The goal is to see if this treatment, combined with the patient’s own healing cells, can improve recovery and repair of the shoulder.

To participate in this trial, patients should be between 65 and 74 years old and have a specific type of rotator cuff injury that affects certain tendons in the shoulder. They need to have a certain level of tendon retraction and fatty degeneration, which can be assessed through pre-operative MRI scans. However, patients with other shoulder problems, certain health conditions, or those who are pregnant cannot join the study. If eligible, participants can expect to undergo surgery using this new treatment and will be monitored to evaluate its effectiveness in helping them heal and regain shoulder function.

Gender

ALL

Eligibility 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