Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Last updated: March 10, 2025
Sponsor: Henry Ford Health System
Overall Status: Active - Recruiting

Phase

4

Condition

Tennis Elbow

Treatment

Smith & Nephew Bioinductive Implant

Lateral Epicondylectomy

Ultrasound Imaging

Clinical Study ID

NCT03718637
12495
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Previous surgery on the currently-affected elbow.

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Smith & Nephew Bioinductive Implant
Phase: 4
Study Start date:
April 17, 2019
Estimated Completion Date:
January 17, 2027

Study 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.

Connect with a study center

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

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