Recruiting

Bioinductive Implant

Sponsor:

Henry Ford Health System

Code:

NCT03718637

Conditions

Tennis Elbow

Lateral Epicondylitis

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smith & Nephew Bioinductive Implant

Lateral Epicondylectomy

Ultrasound Imaging

Study Details

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

Study ID

NCT03718637

Start date

Apr 17, 2019

Status verified date

Mar, 2025

Completion date

Jan 17, 2027

Anticipated

Primary completion date

May 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: Experimental

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

Interventions

Smith & Nephew Bioinductive Implant

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

Lateral Epicondylectomy

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

Ultrasound Imaging

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

Primary outcome measure

  • PROMIS CAT Scores [ Time Frame: Preoperative to 1 year postoperative ]
  • Visual Analog Scale (VAS) for Pain [ Time Frame: Preoperative to 1 year postoperative ]
  • Range of Motion [ Time Frame: Preoperative to 1 year ]

Central Contacts and Locations

Central contacts

Johnny Kasto, MD

3132448078jkasto1@hfhs.org

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Johnny Kasto, MD

3132448078jkasto1@hfhs.org

Principal Investigator:

Stephanie J Muh, MD

More Information

Sponsor

Henry Ford Health System

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Keywords

  • Tennis Elbow
  • Tendinopathy
  • Lateral Epicondylitis
  • Bioinductive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2025-03-12.