Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Phase

N/A

Condition

N/A

Treatment

Tenex

Clinical Study ID

NCT05757739

G23004

Ages 19-70
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Individuals 18-70 years of age
Clinically documented chronic lateral epicondylitis with a minimum of 6 months ofpersistent elbow pain that impedes daily activities.
Failed alternative treatment for > 3 months.

Exclusion

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 blooddisorders.
Failed prior surgical procedure on the affected joint.
No prior effort to treat (stretching, rest, medication) or implementation ofexternal protocol in an effort to improve condition (physical therapy, massagetreatment, rehabilitation techniques).

Study Design

Tenex

February 09, 2023

June 30, 2026

Study 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.

Connect with a study center

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

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