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Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Who can join
Ages 18 and older · Men
Full eligibility criteria
Inclusion Criteria: * Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment. Exclusion Criteria: * Previous surgery on the currently-affected elbow.
About the study
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.
What is being tested
- Smith & Nephew Bioinductive Implant (biological)
- Lateral Epicondylectomy (procedure)
- Ultrasound Imaging (radiation)
Sponsor: Henry Ford Health System · Participants: 40 · Started: Apr 17, 2019
Contact the study team
- Johnny Kasto, MD · Phone: 3132448078
Official record on ClinicalTrials.gov — NCT03718637
Locations in the U.S.
| Michigan | Henry Ford Hospital, Detroit |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.