Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Recruiting
Phase 4
Interventional Study
Rotator Cuff Tears
Rotator Cuff Injuries
Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Brooke Army Medical Center · Federal
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About This Trial
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 …
Trial Locations
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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 humeru…
Contacts