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
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
Impending fracture secondary to a pathologic process, including:
Exclusion Criteria:
Procedure: Femoral venting+ intramedullary nailing · Procedure: Standard intramedullary nailing
Procedure: Standard intramedullary nailing
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Participants will undergo prophylactic intramedullary fixation
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)
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)
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)
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)
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)
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)
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)
Need for postoperative vasopressor or respiratory support
Time frame: Intraoperative through hospital discharge (about 2 to 3 days after surgery)
Number of participants that need ICU admission
Time frame: at hospital discharge (about 2 to 3 days after surgery)
Length of hospital stay
Time frame: at hospital discharge (about 2 to 3 days after surgery)
Number of participants with postoperative hematoma
Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with surgical site infection
Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with wound complications
Time frame: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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
Plan to share: No
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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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The University of Texas Health Science Center, Houston