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Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

RecruitingNAAges 18 Years - 70 YearsAllSean Mc Millan
NCT05757739 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 anes

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📋 Eligibility rules (as published)
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).
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What it tests

  • Tenex Procedure
  • Open Debridement Surgical Intervention Treatment Plan
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Where

10 sites
Virtua Reconstructive Orthopedics
Burlington, United States
Virtua Reconstructive Orthopedics
Cherry Hill, United States
Virtua Reconstructive Orthopedics
Moorestown, United States
Fellowship Surgical Center
Mount Laurel, United States
Surgical Center of South Jersey
Mount Laurel, United States
Virtua Reconstructive Orthopedics
Riverside Park, United States
Virtua Reconstructive Orthopedics
Sewell, United States
Centennial Surgery Center
Voorhees Township, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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