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

N/ANot Yet RecruitingNCT07778238

The University of Texas Health Science Center, Houston10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Femur Fracture

Interventions

Femoral venting+ intramedullary nailingPROCEDURE

Participants will undergo femoral venting prior to prophylactic intramedullary fixation .

Standard intramedullary nailingPROCEDURE

Participants will undergo prophylactic intramedullary fixation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

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)

Central Contacts

Stephen Warner, MD, PhD

CONTACT

(713) 486-6998 Stephen.J.Warner@uth.tmc.edu

Collyn O'Quin

CONTACT

(713) 486-6536 Collyn.OQuin@uth.tmc.edu

Data from ClinicalTrials.gov

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