Actively Recruiting

Phase 4
Age: 18Years +
MALE
NCT03718637

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Led by Henry Ford Health System · Updated on 2025-03-12

40

Participants Needed

1

Research Sites

404 weeks

Total Duration

On this page

Sponsors

H

Henry Ford Health System

Lead Sponsor

S

Smith & Nephew, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment including physical therapy, activity change, and anti-inflammatory treatment.
Not Eligible

You will not qualify if you...

  • Previous surgery on the currently-affected elbow.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

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Research Team

J

Johnny Kasto, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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