Orthopedic Devices Associated With MisadventuresTenexNCT05757739
Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
A study testing Tenex Procedure and Open Debridement Surgical Intervention Treatment Plan in people with Orthopedic Devices Associated With Misadventures, run by Sean Mc Millan at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Orthopedic Devices Associated With Misadventures
- What is being tested?
- Tenex Procedure and Open Debridement Surgical Intervention Treatment Plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Feb 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Virtua Reconstructive Orthopedics
Burlington, New Jersey, 08016
Donna Hoopes, 8563551206, dhoopes@virtua.org
Sean McMillan
- Recruiting
Virtua Reconstructive Orthopedics
Cherry Hill, New Jersey, 08034
Donna Hoopes, 8563551206, dhoopes@virtua.org
Sean McMillan
- Recruiting
Virtua Reconstructive Orthopedics
Moorestown, New Jersey, 08057-3128
Donna Hoopes, 856-355-1206, dhoopes@virtua.org
Thomas Plut
- Recruiting
Fellowship Surgical Center
Mount Laurel, New Jersey, 08054
Donna Hoopes, dhoopes@virtua.org
Sean McMillan
- Recruiting
Surgical Center of South Jersey
Mount Laurel, New Jersey, 08054
Donna Hoopes, dhoopes@virtua.org
Sean McMillan
- Recruiting
Virtua Reconstructive Orthopedics
Riverside Park, New Jersey, 08075
Donna Hoopes, 8563551206, dhoopes@virtua.org
Nathan Bodin
- Recruiting
Virtua Reconstructive Orthopedics
Sewell, New Jersey, 08080
Donna Hoopes, dhoopes@virtua.org
Nathan Bodin
- Recruiting
Centennial Surgery Center
Voorhees Township, New Jersey, 08043
Donna Hoopes, dhoopes@virtua.org
Sean McMillan
- Recruiting
Summit Surgical Center LLC
Voorhees Township, New Jersey, 08043
Donna Hoopes, 8563551206, dhoopes@virtua.org
Nathan Bodin
- Recruiting
Virtua Reconstructive Orthopedics
Voorhees Township, New Jersey, 08043
Donna Hoopes, dhoopes@virtua.org
Nathan Bodin
About this study
Official title: Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
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.
Read the 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 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.
- Being tested
- Tenex Procedure, Open Debridement Surgical Intervention Treatment Plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenex ProcedureProcedure or surgery
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 PlanProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Tenex Treatment Plan | Active comparator | Not described Receives: Procedure: Tenex Procedure |
| Open Debridement Surgical Intervention Treatment Plan | Active comparator | Not described Receives: Procedure: Open Debridement Surgical Intervention Treatment Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation
The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation
Measured: Study Enrollment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start9 Feb 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Devices Associated With MisadventuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sean Mc Millan
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Sean Mcmillan, Dr. Thomas Plut, Dr. Nathan Bodin
- Responsible party
- Sponsor-investigator, Sean Mc Millan, Virtua Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757739
- Sponsor's protocol ID
- G23004
- Acronym
- Tenex
- Status last verified
- May 2026
- First submitted
- 23 Feb 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
- ClinicalTrials.gov ID
- NCT05757739
- Acronym / sponsor ID
- Tenex / G23004
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sean Mc MillanUniversity, hospital or other
- Collaborators
- Dr. Sean Mcmillan, Dr. Thomas Plut, Dr. Nathan Bodin
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenex Treatment Plan | Active comparator | Procedure: Tenex Procedure |
| Open Debridement Surgical Intervention Treatment Plan | Active comparator | Procedure: Open Debridement Surgical Intervention Treatment Plan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenex ProcedureIn 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. | Procedure or surgery | Tenex Treatment Plan |
| Open Debridement Surgical Intervention Treatment PlanOperative 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 | Procedure or surgery | Open Debridement Surgical Intervention Treatment Plan |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenex Procedure and Open Debridement Surgical Intervention Treatment Plan in people with Orthopedic Devices Associated With Misadventures, run by Sean Mc Millan at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna Hoopes (856-355-1206, dhoopes@virtua.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.