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Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

NCT05757739 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Orthopedic Devices Associated With Misadventures

Interventions

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.

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

Sponsors & Collaborators

  • Dr. Sean Mcmillan

    collaborator UNKNOWN

  • Dr. Thomas Plut

    collaborator UNKNOWN

  • Dr. Nathan Bodin

    collaborator UNKNOWN

  • Sean Mc Millan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757739 on ClinicalTrials.gov