Patch aims to cut rotator cuff Re-Tear rate after surgery
NCT ID NCT06289686
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This trial compares standard rotator cuff repair surgery to the same surgery plus a BioEnthesis patch, designed to help tendon reattach to bone more strongly. About 100 adults aged 18–65 with reparable rotator cuff tears will take part. The main goal is to see if the patch reduces the chance of re-tearing within 12 months, as seen on MRI.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BioEnthesis allograft patch
- What this could lead to
- If successful, this patch could lower the high re-tear rate after rotator cuff surgery, leading to better mobility and less pain.
- What could go wrong
- This is a single-center Phase 4 trial with 100 participants. The patch is new, and results may not apply to all patients. Re-tear risk remains.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * DEERS-eligible * Adults, between the ages of 18-65 (inclusive) * Presenting with a rotator cuff tear that is reparable surgically (a reparable tear is defined as tear of the RC where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension) * Ability to undergo surgery to repair rotator cuff tear * Willingness to commit to study procedures including study intervention and a 12-month follow-up * Fluency in speaking, reading, comprehending English * 1-2 tendon full thickness reparable RC tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border) * Patients who have high-grade partial thickness tears where the surgeon elects to complete the tear during surgery before repairing the tendon(s) Exclusion Criteria: * Previous shoulder surgery (excluding acromioplasty or diagnostic arthroscopy) * Inability to receive an MRI * Current (within the past 6 months) tobacco user * Unwilling to remain tobacco free for the duration of the study * Current lower limb injuries requiring walking assist devices such as crutches and walkers * Diagnosed with systemic arthritis * Significant neck pathology * Active joint or systemic infection * Currently enrolled, or plans to enroll, in another clinical trial during this study (that would affect the patient's safety or results of this trial) * Significant muscle paralysis of the shoulder girdle * Currently pregnant or plans to become pregnant during this study * Inability of the surgeon to repair the tear with remaining defect no greater than 10 mm in diameter * Inability of the surgeon to repair the tear with less than 1cm of medialization * Evidence of other significant shoulder pathology (such as Grade III osteoarthritis) * Has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction * Major medical illness that would preclude undergoing surgery * Major psychiatric illness or developmental handicap * Goutallier III classification and above
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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10th Medical Group - Air Force Academy
RECRUITINGAir Force Academy, Colorado, 80840, United States
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Brooke Army Medical Center
RECRUITINGSan Antonio, Texas, 78234, United States
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Duke University
RECRUITINGDurham, North Carolina, 27710, United States
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University of North Carolina Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27514, United States
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Walter Reed National Military Medical Center
RECRUITINGBethesda, Maryland, 20889, United States
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