Recruiting

Open Debridement vs. TenexRandomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Sponsor:

Sean Mc Millan

Code:

NCT05757739

Conditions

Orthopedic Devices Associated With Misadventures

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Tenex Procedure

Open Debridement Surgical Intervention Treatment Plan

Study Details

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.

Conditions

Orthopedic Devices Associated With Misadventures

Study ID

NCT05757739

Start date

Feb 9, 2023

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Tenex Treatment Plan

active comparator: Open Debridement Surgical Intervention Treatment Plan

Interventions

Tenex 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

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 outcome measure

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 ]

Central Contacts and Locations

Central contacts

Donna Hoopes

856-355-1206 dhoopes@virtua.org

Locations

Virtua Reconstructive Orthopedics

Recruiting

Burlington, New Jersey, United States, 08016

Contacts

Donna Hoopes

8563551206 dhoopes@virtua.org

Principal Investigator:

Sean McMillan

Virtua Reconstructive Orthopedics

Recruiting

Cherry Hill, New Jersey, United States, 08034

Contacts

Donna Hoopes

8563551206 dhoopes@virtua.org

Principal Investigator:

Sean McMillan

Virtua Reconstructive Orthopedics

Recruiting

Moorestown, New Jersey, United States, 08057-3128

Contacts

Donna Hoopes

856-355-1206 dhoopes@virtua.org

Fellowship Surgical Center

Recruiting

Mount Laurel, New Jersey, United States, 08054

Contacts

Donna Hoopes

dhoopes@virtua.org

Principal Investigator:

Sean McMillan

Surgical Center of South Jersey

Recruiting

Mount Laurel, New Jersey, United States, 08054

Contacts

Donna Hoopes

dhoopes@virtua.org

Principal Investigator:

Sean McMillan

Virtua Reconstructive Orthopedics

Recruiting

Riverside Park, New Jersey, United States, 08075

Contacts

Donna Hoopes

8563551206 dhoopes@virtua.org

Virtua Reconstructive Orthopedics

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Donna Hoopes

dhoopes@virtua.org

Centennial Surgery Center

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

Donna Hoopes

dhoopes@virtua.org

Principal Investigator:

Sean McMillan

Summit Surgical Center LLC

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

Donna Hoopes

8563551206 dhoopes@virtua.org

Virtua Reconstructive Orthopedics

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

Donna Hoopes

dhoopes@virtua.org

More Information

Sponsor

Sean Mc Millan

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sean Mc Millan on 2026-05-12.