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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

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

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

02

Conditions studied

  • Femur Fracture

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Keywords

  • prophylactic intramedullary fixation
  • femoral vent holes
03

Who can participate

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

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

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
04

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

05

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

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07778238
Lead sponsor
The University of Texas Health Science Center, Houston
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 ↗

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