Clinical Trial

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Recruiting Phase 4
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Record status
This record was last updated March 12, 2025 (before its estimated May 17, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2018-10-23; most recent amendment 2025-03-10.
Status change: Not Yet Recruiting → Recruiting 2022-02-19
Trial Details
NCT Number NCT03718637
Lead Sponsor Henry Ford Health System
Collaborators: Smith & Nephew, Inc.
Conditions Tennis Elbow, Lateral Epicondylitis
Enrollment 40 participants
Start Date 2019-04-17
Primary Completion 2026-05-17 (estimated)
Study Completion 2027-01-17 (estimated)
Updated on ClinicalTrials.gov 2025-03-12