Comparing Tenex Procedure and Open Debridement for Tennis Elbow

This study is comparing two different ways to treat chronic lateral epicondylitis (tennis elbow), which causes ongoing elbow pain. Researchers want to see if the Tenex Procedure or Open Debridement Surgical Intervention Treatment Plan is better at reducing complications and improving how your arm works. The Tenex Procedure uses a special needle and ultrasound to remove damaged tissue with local anesthesia in a doctor's office. Open Debridement is a surgery under general anesthesia where an incision is made to remove damaged tissue. You may be able to join if you are 18-70 years old, have had tennis elbow for at least 6 months, and other treatments haven't worked for over 3 months. The study aims to enroll 90 participants. The current status of this study is unclear.

Study design
This is a randomized controlled trial, meaning you have a 50% chance of receiving either treatment, like flipping a coin. It plans to enroll 90 participants.
What's involved
You will have an initial screening visit. If eligible, you will be randomized to a treatment group, then undergo your assigned procedure. You will have follow-up appointments at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months, and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their treatment.

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

NCT05757739

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Recruiting
NAAges 18–70Interventional
Sean Mc Millan
~90 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Tenex ProcedureOpen Debridement Surgical Intervention Treatment Plan

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation
Measured over Study Enrollment Period
Orthopedic Devices Associated With Misadventures

NCT05757739

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centennial Surgery Center

    Voorhees Township, New Jerseystudy coordinator listed

    Recruiting

  • Fellowship Surgical Center

    Mount Laurel, New Jerseystudy coordinator listed

    Recruiting

  • Summit Surgical Center LLC

    Voorhees Township, New Jerseystudy coordinator listed

    Recruiting

  • Surgical Center of South Jersey

    Mount Laurel, New Jerseystudy coordinator listed

    Recruiting

  • Virtua Reconstructive Orthopedics

    Burlington, New Jerseystudy coordinator listed

    Recruiting

  • Virtua Reconstructive Orthopedics

    Cherry Hill, New Jerseystudy coordinator listed

    Recruiting

  • Virtua Reconstructive Orthopedics

    Moorestown, New Jerseystudy coordinator listed

    Recruiting

  • Virtua Reconstructive Orthopedics

    Riverside Park, New Jerseystudy 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.

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Eligibility criteria

Inclusion

Individuals 18-70 years of age
Clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.
Failed alternative treatment for \> 3 months.

Exclusion

Surgical procedure on affected extremity within last six months.
Dermatological disorder in affected area
Currently pregnant, confirmed via pregnancy test.
Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders.
Failed prior surgical procedure on the affected joint.
No prior effort to treat (stretching, rest, medication) or implementation of external protocol in an effort to improve condition (physical therapy, massage treatment, rehabilitation techniques).
  • The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablationStudy Enrollment Period

    The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation