Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03718637
Study type	Interventional
Source	Henry Ford Health System
Contact	Johnny Kasto, MD
Phone	3132448078
Email	jkasto1@hfhs.org
Status	Recruiting
Phase	Phase 4
Start date	April 17, 2019
Completion date	May 17, 2025

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