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Bioinductive Implant for Tennis Elbow Study

This study is testing a new, FDA-approved implant called the Smith & Nephew Bioinductive Implant for people with tennis elbow (lateral epicondylitis) that hasn't improved with other treatments. This implant is designed to help your tendon regrow and heal after surgery. You could be eligible if you are an adult man whose tennis elbow hasn't gotten better with physical therapy, activity changes, or anti-inflammatory medicines, and you haven't had previous elbow surgery. Participants will either receive the standard surgery (Lateral Epicondylectomy) or the standard surgery plus the bioinductive implant. Researchers will use ultrasound images and other measures to see how well the implant works over one year.

Study design
This study plans to enroll 40 adult men and will randomly assign them to one of two groups: a control group receiving standard surgery, or an experimental group receiving standard surgery plus the implant.
What's involved
Participants will have an ultrasound before surgery and again 6 months after surgery. Researchers will also assess your pain and range of motion from before surgery up to one year afterward.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after their surgery to assess pain, range of motion, and PROMIS CAT scores.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03718637

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Recruiting
PHASE4Ages 18+InterventionalTreatment
Henry Ford Health System
~40 participants
Updated 2025-03-12 on ClinicalTrials.gov
What's tested:Smith & Nephew Bioinductive ImplantLateral EpicondylectomyUltrasound Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PROMIS CAT Scores
Measured over Preoperative to 1 year postoperative
+2 more outcomes measured

Conditions

Tennis Elbow
Lateral Epicondylitis

Explore related trials

Lateral Epicondylitis

NCT03718637

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Henry Ford Hospital

    Detroit, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephanie J Muh, MD · PRINCIPAL_INVESTIGATOR · Henry Ford Health System

Who to contact

Johnny Kasto, MD
[email protected]
3132448078
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

Previous surgery on the currently-affected elbow.

What this trial measures

  • PROMIS CAT ScoresPreoperative to 1 year postoperative

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

  • Visual Analog Scale (VAS) for PainPreoperative to 1 year postoperative

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

  • Range of MotionPreoperative to 1 year

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