Comparing two treatments for Tennis Elbow
Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
This study is testing two different treatments for Tennis Elbow to see which one helps people recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Virtua Health, Inc. Academic / other |
| Locations | 10 sites (Burlington, New Jersey and 9 other locations) |
| Trial ID | NCT05757739 on ClinicalTrials.gov |
What this trial studies
This study compares two treatment options for chronic lateral epicondylitis, commonly known as Tennis Elbow. Participants will be randomly assigned to receive either an Ultrasound-guided Percutaneous Tenotomy Technique or traditional Open Surgical Debridement. The Tenex procedure uses ultrasonic energy to remove damaged tissue with local anesthesia, while the open debridement requires a surgical incision under general anesthesia. Follow-up appointments will monitor patient progress over a year, and participants will complete questionnaires to assess their recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-70 with chronic lateral epicondylitis lasting at least six months and who have not responded to alternative treatments.
Not a fit: Patients who have had recent surgery on the affected elbow or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective treatment for Tennis Elbow, improving patient outcomes and recovery times.
How similar studies have performed: While there have been studies on Tennis Elbow treatments, this specific comparison of the Tenex procedure and open debridement is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals 18-70 years of age * Clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities. * Failed alternative treatment for \> 3 months. Exclusion Criteria: * Surgical procedure on affected extremity within last six months. * Dermatological disorder in affected area * Currently pregnant, confirmed via pregnancy test. * Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders. * Failed prior surgical procedure on the affected joint. * No prior effort to treat (stretching, rest, medication) or implementation of external protocol in an effort to improve condition (physical therapy, massage treatment, rehabilitation techniques).
Where this trial is running
Burlington, New Jersey and 9 other locations
- Virtua Reconstructive Orthopedics — Burlington, New Jersey, United States (Recruiting)
- Virtua Reconstructive Orthopedics — Cherry Hill, New Jersey, United States (Recruiting)
- Virtua Reconstructive Orthopedics — Moorestown, New Jersey, United States (Recruiting)
- Fellowship Surgical Center — Mount Laurel, New Jersey, United States (Recruiting)
- Surgical Center of South Jersey — Mount Laurel, New Jersey, United States (Recruiting)
- Virtua Reconstructive Orthopedics — Riverside Park, New Jersey, United States (Recruiting)
- Virtua Reconstructive Orthopedics — Sewell, New Jersey, United States (Recruiting)
- Centennial Surgery Center — Voorhees Township, New Jersey, United States (Recruiting)
- Summit Surgical Center LLC — Voorhees Township, New Jersey, United States (Recruiting)
- Virtua Reconstructive Orthopedics — Voorhees Township, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Donna Hoopes
- Email: dhoopes@virtua.org
- Phone: 856-355-1206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.