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NCT Number: NCT05757739

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virtua Reconstructive Orthopedics, Burlington, New Jersey, United States

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About this study

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 have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 6 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 patient questionnaires about your progress at visits 3-7.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tenex Procedure

Procedure

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.

Open Debridement Surgical Intervention Treatment Plan

Procedure

Operative treatment will be performed under anesthesia, and debridement of the extensor tendon's common origin will be performed with an open assessment of the tendon origin with tendon repair or reattachment

Primary outcomes

  1. The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation

    Time frame: Study Enrollment Period

    The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Hoopes

CONTACT

[email protected]

856-355-1206

Sponsors and collaborators

Lead sponsor

Sean Mc Millan

Other

Collaborators

  • Dr. Nathan Bodin
  • Dr. Sean Mcmillan
  • Dr. Thomas Plut

Registry information

Official study title

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

Acronym: Tenex

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 7, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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