Clinical trial NCT05757739: Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
Official title: Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Devices Associated With Misadventures
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
Collaborators: name: Dr. Sean Mcmillan
name: Dr. Thomas Plut
name: Dr. Christopher Chung
name: Dr. Raymond Ragland
name: Dr. Nathan Bodin
First posted: 2023-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.

Brief 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 then undergo your procedure and provided referral for physical therapy. You will also have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 5 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 two patient questionnaires about your progress at visits 3-7.

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).

Primary outcomes:
measure: Background: Ultrasound-guided Percutaneous Tenotomy Technique
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Virtua Health Inc
state: New Jersey
city: Cherry Hill
country: United States
facility: Virtua Health and Wellness
state: New Jersey
city: Delran
country: United States
facility: Virtua Hand Surgery
state: New Jersey
city: Moorestown
country: United States
facility: Virtua Cadiac Testing Center
state: New Jersey
city: Voorhees
country: United States
facility: Summit Surgical Center LLC
state: New Jersey
Study officials:
References: