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New treatment option for Rotator Cuff Tears
Official title Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
ClinicalTrials.gov ID: NCT04975581
What this study is testing
What is Allograft Patch?
Allograft Patch is an investigational medicine, being studied as a potential treatment for rotator cuff tears.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Investigators are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and \< 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join if
- Patient aged at least 50 years to 75 years.
- Degenerative cuff tear.
- Large Full thickness rotator cuff tear (≥ 3cm and \< 5 cm ) that is fully repairable.
- Tears diagnosed using MRI scan.
- Ability to consent.
You likely can't join if
- Previous surgery on the affected shoulder.
- Osteoarthritic changes.
- Unable to have MRI Scans.
- Significant neck pathology.
- Cognitive problems or language issue.
- Systemic arthritis
See the full eligibility criteria
- Patient aged at least 50 years to 75 years.
- Degenerative cuff tear.
- Large Full thickness rotator cuff tear (≥ 3cm and \< 5 cm ) that is fully repairable.
- Tears diagnosed using MRI scan.
- Ability to consent.
- Agreement to use of human dermal matrix allograft as augmentative patch
- Previous surgery on the affected shoulder.
- Osteoarthritic changes.
- Unable to have MRI Scans.
- Significant neck pathology.
- Cognitive problems or language issue.
- Systemic arthritis
- Significant dual pathology in the involved shoulder
- Acute Traumatic tears (\< 6 months since injury).
The study team makes the final eligibility decision.
Where it's taking place
- Leicester, United Kingdom
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, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leicester, United Kingdom. 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.