RECRUITING

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2019-04-17
Study Completion:2025-05-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03718637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
  1. * Previous surgery on the currently-affected elbow.

Contacts and Locations

Study Contact

Johnny Kasto, MD
CONTACT
3132448078
jkasto1@hfhs.org

Principal Investigator

Stephanie J Muh, MD
PRINCIPAL_INVESTIGATOR
Henry Ford Health System

Study Locations (Sites)

Henry Ford Hospital
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

  • Stephanie J Muh, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-17
Study Completion Date2025-05-17

Study Record Updates

Study Start Date2019-04-17
Study Completion Date2025-05-17

Terms related to this study

Keywords Provided by Researchers

  • Tennis Elbow
  • Tendinopathy
  • Lateral Epicondylitis
  • Bioinductive

Additional Relevant MeSH Terms

  • Tennis Elbow
  • Lateral Epicondylitis