Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
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
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