Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Launched by VIRTUA HEALTH, INC. · Feb 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for a condition called lateral epicondylitis, commonly known as tennis elbow. This painful condition can make it hard for people to do everyday activities and may require them to take time off work. The trial will compare two methods: one is a traditional surgery called open surgical debridement, where the surgeon makes an incision to remove damaged tissue, and the other is a newer, less invasive procedure called Tenex. In the Tenex procedure, a special needle is used to target the damaged tendon under ultrasound guidance, allowing the doctor to remove the unhealthy tissue without a large incision.

To participate in this study, individuals must be between 18 and 70 years old and have had ongoing elbow pain for at least six months, which has not improved with other treatments. Participants will receive either of the two treatments and will be monitored to see which method works better. It’s important to know that people with certain health conditions or recent surgeries may not be eligible for this trial. If you or someone you know is struggling with tennis elbow and meets the criteria, this trial could provide valuable insights into effective treatment options.

Gender

ALL

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).