Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05757739

Randomized Controlled Trial of Open Surgical Debridement versus Percutaneous Ultrasonic Treatment for Chronic Lateral Epicondylitis (Tennis Elbow)

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

90

Participants Needed

10

Research Sites

52 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

This trial investigates treatments for chronic lateral epicondylitis, also known as tennis elbow, which can cause pain and interfere with daily activities and work. The study aims to compare two treatment methods to determine if one is better than the other for relieving symptoms and improving function. It is a randomized controlled trial led by Sean Mc Millan, focusing on patients who have had symptoms for at least six months and have tried other treatments without success. Participants will be randomly assigned to receive either the Ultrasound-guided Percutaneous Tenotomy Technique (Tenex procedure) or Open Surgical Debridement. The Tenex procedure uses a special needle and ultrasonic energy to remove damaged tissue under local anesthesia in the surgeon's office. Open Surgical Debridement is a traditional surgery involving an incision to remove damaged tissue under anesthesia in a surgery center. Both procedures target the damaged tendon area causing pain. During the study, participants will have follow-up visits at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months after treatment. At each visit, their progress will be monitored through physical exams and questionnaires. The main outcome measured is the comparison of complications and functional results between the two treatments. The total participation period includes the initial screening and one year of follow-up to assess recovery and treatment effects.

CONDITIONS

Brief 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 to 70 years old
  • Clinically documented chronic lateral epicondylitis with at least 6 months of persistent elbow pain affecting daily activities
  • Have tried other treatments for more than 3 months without success
Not Eligible

You will not qualify if you...

  • Surgical procedure on the affected extremity within the last six months
  • Dermatological disorder in the affected area
  • Currently pregnant
  • Blood disorders, autoimmune diseases, conditions requiring immunosuppression, cancer, infections, or sickle cell disease
  • Failed prior surgical procedure on the affected joint
  • No prior efforts to treat the condition such as 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment session with local or general anesthesia depending on procedure

Participants receive either an ultrasound-guided percutaneous Tenotomy (Tenex procedure) or open surgical debridement for chronic lateral epicondylitis.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants have follow-up appointments to monitor progress and complete questionnaires about their recovery.

Visits at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months (in-person)

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Frequently Asked Questions

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