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RECRUITING
NCT03718637
PHASE4

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Sponsor: Henry Ford Health System

View on ClinicalTrials.gov

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.

Official title: Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2019-04-17

Completion Date

2027-01-17

Last Updated

2025-03-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Smith & Nephew Bioinductive Implant

A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.

PROCEDURE

Lateral Epicondylectomy

This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

RADIATION

Ultrasound Imaging

An ultrasound will be performed on each patient both preoperatively and at 6 months.

Locations (1)

Henry Ford Hospital

Detroit, Michigan, United States