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

ConditionFemur Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of an impending femur fracture requiring prophylactic intramedullary fixation

Long-term bisphosphonate use, or

Oncologic disease without radiographic evidence of cortical disruption

Ability to provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Femoral venting+ intramedullary nailing

    Procedure/Surgery

    Participants will undergo femoral venting prior to prophylactic intramedullary fixation .

  • Standard intramedullary nailing

    Procedure/Surgery

    Participants will undergo prophylactic intramedullary fixation

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: