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New treatment option for Rotator Cuff Tears
Official title Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
ClinicalTrials.gov ID: NCT05855759
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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,
You likely can't join if
- patients affected by osteoarthritic degeneration,
- frozen shoulder,
- symptomatic acromioclavicular arthritis,
- revision surgeries,
- inability to cope with post-operative rehabilitation regimen,
- autoimmune connective tissue disease,
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, BO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, BO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.