RecruitingNot ApplicableNCT05757739

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

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


Sponsor

Sean Mc Millan

Enrollment

90 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Open Debridement Surgical Intervention Treatment Plan and Tenex Procedure for people with orthopedic devices associated with misadventures. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETenex 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.

PROCEDUREOpen 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


Locations(10)

Virtua Reconstructive Orthopedics

Burlington, New Jersey, United States

Virtua Reconstructive Orthopedics

Cherry Hill, New Jersey, United States

Virtua Reconstructive Orthopedics

Moorestown, New Jersey, United States

Fellowship Surgical Center

Mount Laurel, New Jersey, United States

Surgical Center of South Jersey

Mount Laurel, New Jersey, United States

Virtua Reconstructive Orthopedics

Riverside Park, New Jersey, United States

Virtua Reconstructive Orthopedics

Sewell, New Jersey, United States

Centennial Surgery Center

Voorhees Township, New Jersey, United States

Summit Surgical Center LLC

Voorhees Township, New Jersey, United States

Virtua Reconstructive Orthopedics

Voorhees Township, New Jersey, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05757739