Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Recruiting now · Phase 4

Conditions studied: Tennis Elbow, Lateral Epicondylitis

In brief

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.

Key facts

Study ID

NCT03718637

Run by

Henry Ford Health System

People needed

40

Starts

2019-04-17

Expected to finish

2027-01-17

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Previous surgery on the currently-affected elbow.

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.