Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
Start Date
2/9/2023
Completion Date
12/1/2028
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.
Detailed Description
During the initial screening visit, the physician will obtain your medical history and perform a physical exam. If you pass the screening, you will be randomized into either Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. It will be a 50% chance. It will be compared to flipping a coin. Once you have been placed in your treatment group, your treatment will be scheduled. You will have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 6 weeks (visit 4), 3 months (visit 5) 6 month (visit 6), and 12 month (visit 7) time points. You will also be requested to complete patient questionnaires about your progress at visits 3-7.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Tenex Procedure
Open Debridement Surgical Intervention Treatment Plan
Conditions
Locations
Virtua Reconstructive Orthopedics
Burlington, New Jersey 08016
United States
Virtua Reconstructive Orthopedics
Cherry Hill, New Jersey 08034
United States
Virtua Reconstructive Orthopedics
Moorestown, New Jersey 08057-3128
United States
Fellowship Surgical Center
Mount Laurel, New Jersey 08054
United States
Surgical Center of South Jersey
Mount Laurel, New Jersey 08054
United States
Virtua Reconstructive Orthopedics
Riverside Park, New Jersey 08075
United States
Virtua Reconstructive Orthopedics
Sewell, New Jersey 08080
United States
Centennial Surgery Center
Voorhees Township, New Jersey 08043
United States
Summit Surgical Center LLC
Voorhees Township, New Jersey 08043
United States
Virtua Reconstructive Orthopedics
Voorhees Township, New Jersey 08043
United States