Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing
1 other identifier
interventional
10
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 1, 2027
August 21, 2026
July 1, 2026
11 months
August 17, 2026
August 17, 2026
Conditions
Keywords
Outcome Measures
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.
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 (13)
Change in Embolic Burden as assessed by change in Heart rate
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
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
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
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
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)
- +8 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Participants will undergo prophylactic intramedullary fixation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen J Warner, MD, PhD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 17, 2026
First Posted
August 21, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
August 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share