NCT06289686 Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
| NCT ID | NCT06289686 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brooke Army Medical Center |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-07-28 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-07-28 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.
Eligibility Criteria
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
Contact & Investigator
Jonathan Dickens, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06289686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06289686 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06289686 currently recruiting?
Yes, NCT06289686 is actively recruiting participants. Contact the research team at David.J.Tennent.mil@health.mil for enrollment information.
Where is the NCT06289686 trial being conducted?
This trial is being conducted at Air Force Academy, United States, Bethesda, United States, Chapel Hill, United States, Durham, United States and 1 additional location.
Who is sponsoring the NCT06289686 clinical trial?
NCT06289686 is sponsored by Brooke Army Medical Center. The principal investigator is Jonathan Dickens, MD at Duke University. The trial plans to enroll 100 participants.