Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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