ClinicalTrials.gg
Not yet recruitingNCT07778238Updated Aug 21, 2026

Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing

An interventional study of Femoral venting+ intramedullary nailing and Standard intramedullary nailing in Femur Fracture, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 46 studies in Femoral Fractures with a site in United States — 6 open to participants now, 7 under way, none of them phase 3. Femoral Fractures · United States.

Planned enrollment
20th of 29
10 · median 55
Started
2026
with 1 other
No phase
21 of 46
3 open now
Registered
46th of 46
by date

Among the 46 studies in Femoral Fractures with a site in United States, this one is the 20th largest by planned enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2026, is one of 21 with no phase, and was the 46th registered.

Femoral Fractures

186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.

Browse Femoral Fractures studies →

Open to participants now

6 of the 46 studies in Femoral Fractures with a site in United States are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 25 Femoral Fractures studies recruiting now, 14 (56%) set no upper age limit and 2 (8%) stop at 75 or younger; 2 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to measure intraoperative embolic burden during prophylactic intramedullary nailing of impending femur fractures in patients treated with versus without venting, to find the association between embolic burden and intraoperative physiologic changes, measured using standard anesthesia monitors and charted data, to measure Immediate and short-term cardiopulmonary outcomes assessed during hospitalization and to assess procedure-related complications associated with venting

03

Conditions studied

  • Femur Fracture

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Keywords

  • prophylactic intramedullary fixation
  • femoral vent holes
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Procedure: Femoral venting+ intramedullary nailing · Procedure: Standard intramedullary nailing

  • Active comparator
    Control Group

    Procedure: Standard intramedullary nailing

Interventions

  • ProcedureFemoral venting+ intramedullary nailing

    Participants will undergo femoral venting prior to prophylactic intramedullary fixation .

  • ProcedureStandard intramedullary nailing

    Participants will undergo prophylactic intramedullary fixation

06

What researchers measure

Primary outcomes

  1. Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)

    Embolic burden is defined as the presence, frequency, and severity (graded semi-quantitatively) of echogenic embolic events within the right atrium, right ventricle, and pulmonary artery outflow tract.

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)

Secondary outcomes

  1. Change in Embolic Burden as assessed by change in Heart rate

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)

  2. Change in Embolic Burden as assessed by change in Mean arterial pressure

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)

  3. Change in Embolic Burden as assessed by change in oxygen saturation

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)

  4. Change in Embolic Burden as assessed by change in end-tidal carbon dioxide

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)

  5. Embolic Burden as assessed by change in vasopressor requirement

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)

  6. Embolic Burden as assessed by change in arterial blood gas parameters (PaO₂, partial pressure of carbon dioxide in arterial blood(PaCO₂), A-a gradient when obtained as part of clinical care).

    Time frame: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)

  7. Need for postoperative vasopressor or respiratory support

    Time frame: Intraoperative through hospital discharge (about 2 to 3 days after surgery)

  8. Number of participants that need ICU admission

    Time frame: at hospital discharge (about 2 to 3 days after surgery)

  9. Length of hospital stay

    Time frame: at hospital discharge (about 2 to 3 days after surgery)

  10. Number of participants with postoperative hematoma

    Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up

  11. Number of participants with surgical site infection

    Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up

  12. Number of participants with wound complications

    Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up

  13. Number of participants with peri-implant fracture or iatrogenic fracture

    Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.

Of 50 non-industry interventional studies with no phase under Femoral Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's planned 11 months is below that.

Counting every sponsor, half of 53 studies reached it within 23 months; a quarter within 9 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 21, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Aug 1, 2027
CompletionEst.
Aug 1, 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07778238
Responsible party
Stephen Warner (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Aug 21, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Stephen Warner, MD, PhD
Contact
Stephen.J.Warner@uth.tmc.edu
(713) 486-6998
Collyn O'Quin
Contact
Collyn.OQuin@uth.tmc.edu
(713) 486-6536
Stephen J Warner, MD, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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