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Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

NCT03718637 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-12

No results posted yet for this 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.

Conditions

  • Tennis Elbow
  • Lateral Epicondylitis

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Stephanie J Muh, MD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2026-05-17
Completion
2027-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718637 on ClinicalTrials.gov