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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: Femoral venting+ intramedullary nailing; Procedure: Standard intramedullary nailing

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Warner, MD, PhD; Phone Number: (713) 486-6998; Email: Stephen.J.Warner@uth.tmc.edu
• Study Contact Backup: Name: Collyn O'Quin; Phone Number: (713) 486-6536; Email: Collyn.OQuin@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Collyn O'Quin; Phone Number: (713) 486-6536; Email: Collyn.OQuin@uth.tmc.edu
      • Contact: Stephen J Warner, MD, PhD; Phone Number: (713) 486-6998; Email: Stephen.J.Warner@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Procedure: Femoral venting+ intramedullary nailing; Participants will undergo femoral venting prior to prophylactic intramedullary fixation .; Procedure: Standard intramedullary nailing; Participants will undergo prophylactic intramedullary fixation
Active Comparator: Control Group	Procedure: Standard intramedullary nailing; Participants will undergo prophylactic intramedullary fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
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).	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	Intraoperative through hospital discharge (about 2 to 3 days after surgery)
Number of participants that need ICU admission	at hospital discharge (about 2 to 3 days after surgery)
Length of hospital stay	at hospital discharge (about 2 to 3 days after surgery)
Number of participants with postoperative hematoma	During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with surgical site infection	During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
Number of participants with wound complications	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	During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Stephen J Warner, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: prophylactic intramedullary fixation; femoral vent holes
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: HSC-MS-26-0228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No