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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07778238
Status
Not Yet Recruiting

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Conditions

  • Femur Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Femoral venting+ intramedullary nailing — PROCEDURE
    Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
  • Standard intramedullary nailing — PROCEDURE
    Participants will undergo prophylactic intramedullary fixation

Study Details

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

Key Dates

First listed
Aug 21, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
  • Active Comparator: Control Group

Primary Outcome Measure

Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE) [ 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Stephen J Warner, MD, PhD
[email protected]
(713) 486-6998
Collyn O'Quin
[email protected]
(713) 486-6536

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By research site
The University of Texas Health Science Center at Houston· Houston, TX