RecruitingPhase 4NCT03718637

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

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


Sponsor

Henry Ford Health System

Enrollment

40 participants

Start Date

Apr 17, 2019

Study Type

INTERVENTIONAL

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria1

  • Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.

Exclusion Criteria1

  • Previous surgery on the currently-affected elbow.

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Interventions

BIOLOGICALSmith & Nephew Bioinductive Implant

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

PROCEDURELateral Epicondylectomy

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

RADIATIONUltrasound Imaging

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


Locations(1)

Henry Ford Hospital

Detroit, Michigan, United States

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NCT03718637