Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

🩺 Protocol 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.

Primary Research Facility: Henry Ford Hospital (Detroit, Michigan)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Tennis Elbow?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older? • (Protocol specifies male participants only)

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required clinic visits at Henry Ford Hospital (Detroit, Michigan)?

🔍 Logistical Requirement: Site at Henry Ford Hospital

📍 Primary Site Map

Site: Henry Ford Hospital — Detroit, Michigan

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.