Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex (Tenex)

May 6, 2026 updated by: Sean Mc Millan

Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.

Lateral epicondylitis (Tennis Elbow) can cause pain and keep individuals from completing their daily activities and require them to miss work. There are currently different treatment options to address tennis elbow. However surgeons do not know if one is better than the other. This study will compare two treatment options for tennis elbow. Participants will either be treated by Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. Traditional open surgical debridement is a surgical procedure that requires the surgeon to make an incision to remove the damaged tissue. This procedure is done under anesthesia in a surgery center. In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

During the initial screening visit, the physician will obtain your medical history and perform a physical exam. If you pass the screening, you will be randomized into either Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. It will be a 50% chance. It will be compared to flipping a coin.

Once you have been placed in your treatment group, your treatment will be scheduled. You will have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 6 weeks (visit 4), 3 months (visit 5) 6 month (visit 6), and 12 month (visit 7) time points. You will also be requested to complete patient questionnaires about your progress at visits 3-7.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Burlington, New Jersey, United States, 08016
        • Recruiting
        • Virtua Reconstructive Orthopedics
        • Principal Investigator:
          • Sean McMillan
        • Contact:
        • Sub-Investigator:
          • Thomas Plut
      • Cherry Hill, New Jersey, United States, 08034
        • Recruiting
        • Virtua Reconstructive Orthopedics
        • Principal Investigator:
          • Sean McMillan
        • Contact:
      • Moorestown, New Jersey, United States, 08057-3128
        • Recruiting
        • Virtua Reconstructive Orthopedics
        • Contact:
        • Sub-Investigator:
          • Thomas Plut
      • Mount Laurel, New Jersey, United States, 08054
        • Recruiting
        • Surgical Center of South Jersey
        • Principal Investigator:
          • Sean McMillan
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:
      • Mount Laurel, New Jersey, United States, 08054
        • Recruiting
        • Fellowship Surgical Center
        • Principal Investigator:
          • Sean McMillan
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:
      • Riverside Park, New Jersey, United States, 08075
        • Recruiting
        • Virtua Reconstructive Orthopedics
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Virtua Reconstructive Orthopedics
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • Centennial Surgery Center
        • Principal Investigator:
          • Sean McMillan
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • Summit Surgical Center LLC
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • Virtua Reconstructive Orthopedics
        • Sub-Investigator:
          • Nathan Bodin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients with clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tenex Treatment Plan
Procedure: Tenex Procedure
In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office.
Active Comparator: Open Debridement Surgical Intervention Treatment Plan
Procedure: Open Debridement Surgical Intervention Treatment Plan
Operative treatment will be performed under anesthesia, and debridement of the extensor tendon's common origin will be performed with an open assessment of the tendon origin with tendon repair or reattachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation
Time Frame: Study Enrollment Period
The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation
Study Enrollment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sean Mc Millan

Collaborators

Dr. Sean Mcmillan
Dr. Thomas Plut
Dr. Nathan Bodin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • G23004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orthopedic Devices Associated With Misadventures

Clinical Trials on Tenex Procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe