Femoral Venting for Femur Fractures

SW
CO
Overseen ByCollyn O'Quin
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

SJ

Stephen J Warner, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for people who need preventive surgery to strengthen their thigh bone (femur) because it is at risk of breaking. Specific inclusion and exclusion criteria are not listed, but generally applies to those scheduled for this type of procedure.

Inclusion Criteria

Ability to provide informed consent
I am at risk for a bone fracture due to disease or medication, but my bone shows no visible break.
I have a femur at risk of fracture and need preventive surgery to stabilize it.

Exclusion Criteria

I do not have any surgical issues that prevent accurate heart ultrasound readings.
Inability to obtain adequate intraoperative transthoracic echocardiography (TTE) imaging windows for visualization of right-sided cardiac structures
I cannot safely have a TTE heart test as determined by anesthesia.

What Are the Treatments Tested in This Trial?

Interventions

  • Femoral venting + intramedullary nailing
  • Standard intramedullary nailing

Trial Overview

The study compares two surgical methods: standard intramedullary nailing versus the same procedure with an added venting hole in the femur. It looks at how these approaches affect blood vessel blockages during and after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment2 Interventions
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+