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Rotator Cuff Repair with BioEnthesis™ Augmentation Study

This study is looking at ways to improve rotator cuff (shoulder) surgery. Rotator cuff tears are common, and after standard surgery, the tendon can re-tear in many cases. Researchers are testing a new technology called BioEnthesis, which is an allograft patch (tissue from a donor) designed to create a stronger connection between the tendon and bone. You would either receive a standard rotator cuff repair using sutures and anchors, or a repair that also includes the BioEnthesis patch. The main goal is to see if the BioEnthesis patch can reduce the number of re-tears after surgery. This study is for adults aged 18 to 65 who have a surgically repairable rotator cuff tear. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants. It compares two surgical methods for rotator cuff repair.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed after their surgery for re-tear rates at 3 months, 6 months, and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06289686

Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Brooke Army Medical Center
~100 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Rotator cuff repairs with BioEnthesis augmentationRotator cuff repairs without BioEnthesis augmentation

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rates of re-tear
Measured over Post-operation at 3-months, 6-months, and 12-months

Conditions

Rotator Cuff Tears
Rotator Cuff Injuries
Surgery

Explore related trials

Rupture of rotator cuff of shoulder

NCT06289686

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • 10th Medical Group - Air Force Academy

    Air Force Academy, Coloradostudy coordinator listed

    Recruiting

  • Brooke Army Medical Center

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jonathan Dickens, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

David J Tennent, MD
[email protected]
210-916-2048
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rates of re-tearPost-operation at 3-months, 6-months, and 12-months

    Re-tear rates following rotator cuff repair using BioEnthesis versus standard of care. Assessed with (1) 12-month follow-up shoulder MRI and assigning Sugaya Classification, and (2) adverse events evaluation at each follow-up timepoint