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Can a simple hole prevent dangerous emboli during bone surgery?

NCT ID NCT07778238

Disease control Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether making a small venting hole in the femur before inserting a stabilizing rod can reduce the number of fat or bone marrow emboli that travel to the heart and lungs during surgery. It includes 10 people with impending femur fractures who need prophylactic intramedullary nailing. Researchers will measure embolic load using echocardiography and monitor heart rate, blood pressure, and oxygen levels to see if venting helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Femoral venting procedure during intramedullary nailing
What this could lead to
If effective, femoral venting could reduce the risk of embolic complications during prophylactic intramedullary nailing, potentially improving patient safety and outcomes.
What could go wrong
This is a small feasibility study with only 10 participants, so results may not be conclusive. The procedure itself carries risks, and the benefit may not be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of an impending femur fracture requiring prophylactic intramedullary fixation * Impending fracture secondary to a pathologic process, including: * Long-term bisphosphonate use, or * Oncologic disease without radiographic evidence of cortical disruption * Ability to provide informed consent Exclusion Criteria: * Inability to obtain adequate intraoperative transthoracic echocardiography (TTE) imaging windows for visualization of right-sided cardiac structures * Inability to tolerate or safely undergo TTE monitoring per anesthesia determination * Any intraoperative technical limitation preventing reliable echocardiographic data acquisition

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Conditions

The condition(s) this trial relates to.

Femoral Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Femur fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

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