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NCT Number: NCT07778238

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

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

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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral venting+ intramedullary nailing

Procedure

Participants will undergo femoral venting prior to prophylactic intramedullary fixation .

Standard intramedullary nailing

Procedure

Participants will undergo prophylactic intramedullary fixation

Primary outcomes

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

    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)

    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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Collyn O'Quin

CONTACT

[email protected]

(713) 486-6536

Stephen Warner, MD, PhD

CONTACT

[email protected]

(713) 486-6998

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing: A Feasibility Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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