Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

NCT03718637 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 12495
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tennis Elbow; Lateral Epicondylitis

Keywords

Tennis Elbow; Tendinopathy; Lateral Epicondylitis; Bioinductive

Outcome Measures

Primary Outcomes (3)

• PROMIS CAT Scores

  A short 5 minute survey asking questions about physical function, pain, and mental health

  Preoperative to 1 year postoperative

• Visual Analog Scale (VAS) for Pain

  Traditional 1 to 10, subjective rating of pain the patient is experiencing

  Preoperative to 1 year postoperative

• Range of Motion

  Standard range of motion values collected by the surgeon during preoperative and followup visits

  Preoperative to 1 year

Study Arms (2)

Control

ACTIVE COMPARATOR

Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.

Procedure: Lateral Epicondylectomy; Radiation: Ultrasound Imaging

Experimental

EXPERIMENTAL

Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.

Biological: Smith & Nephew Bioinductive Implant; Procedure: Lateral Epicondylectomy; Radiation: Ultrasound Imaging

Interventions

Smith & Nephew Bioinductive Implant BIOLOGICAL

A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.

Also known as: Bioinductive Patch

Experimental

Lateral Epicondylectomy PROCEDURE

This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

Control; Experimental

Ultrasound Imaging RADIATION

An ultrasound will be performed on each patient both preoperatively and at 6 months.

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Tennis Elbow; Tendinopathy

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Stephanie J Muh, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnny Kasto, MD

CONTACT

3132448078; jkasto1@hfhs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Service Chief, Principal Investigator

Model Details: Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for lateral epicondylitis: tendon debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in preoperative and postoperative ultrasound imaging studies.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: April 17, 2019
• Primary Completion (Estimated): May 17, 2026
• Study Completion (Estimated): January 17, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)