Study of Surgery With or Without Bioinductive Patch Implant for Treating Tennis Elbow Lateral Epicondylitis

What this Trial Is About

Researchers are evaluating the effectiveness of a new, FDA-approved bioinductive patch for patients with lateral epicondylitis, also known as tennis elbow. This condition affects the tendons around the elbow and can cause pain and limited movement. The study compares the standard surgical treatment to surgery combined with this bioinductive implant to see if the patch helps tendon regrowth and healing after surgery. Participants will be randomly assigned to one of two groups. The control group will receive the standard surgery called lateral epicondylectomy, which removes damaged tendon tissue. The experimental group will undergo the same surgery but with the addition of the bioinductive patch implanted during the procedure. Ultrasound imaging will be used before surgery and six months afterward to monitor tendon healing. Throughout the study, participants will be followed for one year with assessments including PROMIS CAT scores, a pain scale called the Visual Analog Scale VAS, and range of motion measurements. These will be taken before surgery and at various points up to one year after surgery. The study aims to determine if adding the bioinductive patch improves recovery compared to surgery alone.

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)