Rotator cuff repair with BioEnthesis augmentation vs without augmentation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial compares rotator cuff repairs performed with BioEnthesis augmentation to repairs without augmentation. Eligible participants are adults 18–65 with reparable rotator cuff tears who are undergoing surgery and fluent in English. All participants will complete a 12-month follow-up to assess healing and function. The study is sponsored by Brooke Army Medical Center with Sparta Biopharma as a collaborator and involves multiple U.S. sites.

Why it matters

Who can join: the full rules

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

Where it's running

• 10th Medical Group - Air Force Academy
  Air Force Academy, Colorado, United States Recruiting
• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Recruiting
• University of North Carolina Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• Brooke Army Medical Center
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Jonathan Dickens, MD — Duke University
• Study coordinator: David J Tennent, MD
• Email: David.J.Tennent.mil@health.mil
• Phone: 210-916-2048

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.