Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03718637
• Other study ID #: 12495
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2019
• Est. completion date: May 17, 2025

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: Johnny Kasto, MD
• Phone: 3132448078
• Email: jkasto1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 17, 2025
• Est. primary completion date: May 17, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous surgery on the currently-affected elbow.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS CAT Scores	A short 5 minute survey asking questions about physical function, pain, and mental health	Preoperative to 1 year postoperative
Primary	Visual Analog Scale (VAS) for Pain	Traditional 1 to 10, subjective rating of pain the patient is experiencing	Preoperative to 1 year postoperative
Primary	Range of Motion	Standard range of motion values collected by the surgeon during preoperative and followup visits	Preoperative to 1 year