Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05757739

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Led by Sean Mc Millan · Updated on 2026-05-12

90

Participants Needed

10

Research Sites

303 weeks

Total Duration

On this page

Sponsors

S

Sean Mc Millan

Lead Sponsor

D

Dr. Sean Mcmillan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 18-70 years of age
  • Clinically documented chronic lateral epicondylitis with at least 6 months of persistent elbow pain limiting daily activities
  • Failed alternative treatments for more than 3 months
Not Eligible

You will not qualify if you...

  • Surgical procedure on the affected arm or elbow within the last 6 months
  • Skin disorders in the affected area
  • Currently pregnant, confirmed by pregnancy test
  • Blood disorders, autoimmune diseases, cancer, ongoing infections, or need for immunosuppressive treatment
  • Previous failed surgery on the affected joint
  • No prior efforts to treat the condition with stretching, rest, medication, physical therapy, massage, or rehabilitation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Virtua Reconstructive Orthopedics

Burlington, New Jersey, United States, 08016

Actively Recruiting

2

Virtua Reconstructive Orthopedics

Cherry Hill, New Jersey, United States, 08034

Actively Recruiting

3

Virtua Reconstructive Orthopedics

Moorestown, New Jersey, United States, 08057-3128

Actively Recruiting

4

Fellowship Surgical Center

Mount Laurel, New Jersey, United States, 08054

Actively Recruiting

5

Surgical Center of South Jersey

Mount Laurel, New Jersey, United States, 08054

Actively Recruiting

6

Virtua Reconstructive Orthopedics

Riverside Park, New Jersey, United States, 08075

Actively Recruiting

7

Virtua Reconstructive Orthopedics

Sewell, New Jersey, United States, 08080

Actively Recruiting

8

Centennial Surgery Center

Voorhees Township, New Jersey, United States, 08043

Actively Recruiting

9

Summit Surgical Center LLC

Voorhees Township, New Jersey, United States, 08043

Actively Recruiting

10

Virtua Reconstructive Orthopedics

Voorhees Township, New Jersey, United States, 08043

Actively Recruiting

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Research Team

D

Donna Hoopes

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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