BioEnthesis Study (Rotator Cuff Repair) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to test if an experimental medical device called the Bioenthesis® implant (the study device) is a safe and effective option for people who are having surgery to repair a torn rotator cuff. The study device is a bubble gum strip-sized, sponge-like scaffold that is made of real human tissue. The implant has two layers: a soft tissue layer to merge with your tendon, and a hard tissue layer to allow a patient's own stem cells to populate the implant from the bone marrow.
Desgarros del manguito rotador
Who Can Participate in the Study?
Adults ages 18-65 who:
- Are diagnosed with a rotator cuff tear that can be repaired surgically (a reparable tear is defined as a 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)
- Have 1-2 tendon full thickness reparable rotator cuff tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus
- Can speak English
- Have never had shoulder surgery before this one
- Do not have osteoarthritis or muscle paralysis in the affected shoulder
For more information, contact the study team at cassandra.rhodes@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either have the study device used as part of your rotator cuff repair surgery or to have the standard surgery performed (no implant).
After your surgery, you will return to our clinic at the following times:
- 3 months after surgery
- 6 months after surgery
- 12 months after surgery
During each of these visits, you will have shoulder function tests done and answer questionnaires. You will also have an MRI taken of your shoulder at the final study visit.
Study Details
