NCT05757739 Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
| NCT ID | NCT05757739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sean Mc Millan |
| Condition | Orthopedic Devices Associated With Misadventures |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-02-09 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-02-09 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05757739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Orthopedic Devices Associated With Misadventures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05757739 currently recruiting?
Yes, NCT05757739 is actively recruiting participants. Contact the research team at dhoopes@virtua.org for enrollment information.
Where is the NCT05757739 trial being conducted?
This trial is being conducted at Burlington, United States, Cherry Hill, United States, Moorestown, United States, Mount Laurel, United States and 6 additional locations.
Who is sponsoring the NCT05757739 clinical trial?
NCT05757739 is sponsored by Sean Mc Millan. The trial plans to enroll 90 participants.