RECRUITING

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.

Quick Facts

Study Start:2023-02-09
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05757739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals 18-70 years of age
  2. * Clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.
  3. * Failed alternative treatment for \> 3 months.
  1. * Surgical procedure on affected extremity within last six months.
  2. * Dermatological disorder in affected area
  3. * Currently pregnant, confirmed via pregnancy test.
  4. * Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders.
  5. * Failed prior surgical procedure on the affected joint.
  6. * 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).

Contacts and Locations

Study Contact

Donna Hoopes
CONTACT
856-355-1206
dhoopes@virtua.org

Study Locations (Sites)

Virtua Health Inc
Burlington, New Jersey, 08016
United States
Virtua Health and Wellness
Cherry Hill, New Jersey, 08033
United States
Virtua Hand Surgery
Delran, New Jersey, 08075
United States
Virtua Cadiac Testing Center
Moorestown, New Jersey, 08057-3128
United States
Summit Surgical Center LLC
Voorhees, New Jersey, 08043
United States

Collaborators and Investigators

Sponsor: Virtua Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-09
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-02-09
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Orthopedic Devices Associated With Misadventures