Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

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.

Conditions

Orthopedic Devices Associated With Misadventures

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Study Overview

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Study Details

Study overview

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.

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

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Condition
Orthopedic Devices Associated With Misadventures
Intervention / Treatment

-

Contacts and Locations

Burlington

Virtua Health Inc, Burlington, New Jersey, United States, 08016

Cherry Hill

Virtua Health and Wellness, Cherry Hill, New Jersey, United States, 08033

Delran

Virtua Hand Surgery, Delran, New Jersey, United States, 08075

Moorestown

Virtua Cadiac Testing Center, Moorestown, New Jersey, United States, 08057-3128

Voorhees

Summit Surgical Center LLC, Voorhees, New Jersey, United States, 08043

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

19 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Virtua Health, Inc.,

Study Record Dates

2025-06