Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
Tenex
1 other identifier
observational
90
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2023
CompletedFirst Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJanuary 22, 2025
January 1, 2025
2.8 years
February 23, 2023
January 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Background: Ultrasound-guided Percutaneous Tenotomy Technique
Background: Ultrasound-guided Percutaneous Tenotomy Technique
3 months
Interventions
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
Patients with clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virtua Health, Inc.lead
- Dr. Sean Mcmillancollaborator
- Dr. Thomas Plutcollaborator
- Dr. Christopher Chungcollaborator
- Dr. Raymond Raglandcollaborator
- Dr. Nathan Bodincollaborator
Study Sites (5)
Virtua Health Inc
Burlington, New Jersey, 08016, United States
Virtua Health and Wellness
Cherry Hill, New Jersey, 08033, United States
Virtua Cadiac Testing Center
Moorestown, New Jersey, 08057-3128, United States
Virtua Hand Surgery
Riverside Park, New Jersey, 08075, United States
Summit Surgical Center LLC
Voorhees Township, New Jersey, 08043, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2023
First Posted
March 7, 2023
Study Start
February 9, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
January 22, 2025
Record last verified: 2025-01