Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Recruiting

• Conditions: Orthopedic Devices Associated With Misadventures

• Registration Number: NCT05757739
• Lead Sponsor: Virtua Health, Inc.

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.

Study Timeline

• Study Start: 2023-02-09
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Background: Ultrasound-guided Percutaneous Tenotomy Technique	3 months	Background: Ultrasound-guided Percutaneous Tenotomy Technique

Trial Locations

Locations (5)

Virtua Health Inc; 🇺🇸 Burlington, New Jersey, United States

Virtua Cadiac Testing Center; 🇺🇸 Moorestown, New Jersey, United States

Virtua Health and Wellness; 🇺🇸 Cherry Hill, New Jersey, United States

Virtua Hand Surgery; 🇺🇸 Delran, New Jersey, United States

Summit Surgical Center LLC; 🇺🇸 Voorhees, New Jersey, United States