Femur Fracture
Conditions
Keywords
prophylactic intramedullary fixation, femoral vent holes
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
Interventions
PROCEDUREFemoral venting+ intramedullary nailing
Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
PROCEDUREStandard intramedullary nailing
Participants will undergo prophylactic intramedullary fixation
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE) | baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery) | 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. |
Secondary
| 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 |
Countries
United States
Contacts
CONTACTStephen Warner, MD, PhD
CONTACTCollyn O'Quin
PRINCIPAL_INVESTIGATORStephen J Warner, MD, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed