About this trial
The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomize into one of two groups: control and investigational. Patients in the "control group" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.
Eligibility criteria
Qualifiers
Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
Disqualifiers
Previous surgery on the currently-affected elbow.
Trial design
Treatments tested in this trial
- Smith & Nephew Bioinductive Implant
- Lateral Epicondylectomy
- Ultrasound Imaging
Treatment groups
Sponsors and collaborators
Henry Ford Health System
Lead sponsor
Smith & Nephew, Inc.
Collaborator