NCT03718637

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . 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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-17
• Primary completion: 2026-05-17
• Completion: 2027-01-17
• First posted: 2018-10-24
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study