Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing
17 de agosto de 2026 actualizado por: Stephen Warner, The University of Texas Health Science Center, Houston
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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Stephen Warner, MD, PhD
- Número de teléfono: (713) 486-6998
- Correo electrónico: Stephen.J.Warner@uth.tmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Collyn O'Quin
- Número de teléfono: (713) 486-6536
- Correo electrónico: Collyn.OQuin@uth.tmc.edu
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
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Contacto:
- Collyn O'Quin
- Número de teléfono: (713) 486-6536
- Correo electrónico: Collyn.OQuin@uth.tmc.edu
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Contacto:
- Stephen J Warner, MD, PhD
- Número de teléfono: (713) 486-6998
- Correo electrónico: Stephen.J.Warner@uth.tmc.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Grupo de Intervención
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Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Participants will undergo prophylactic intramedullary fixation
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Comparador activo: Grupo de control
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Participants will undergo prophylactic intramedullary fixation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
Periodo de tiempo: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
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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.
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baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Embolic Burden as assessed by change in Heart rate
Periodo de tiempo: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
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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
Periodo de tiempo: baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
|
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
Periodo de tiempo: 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)
|
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
Periodo de tiempo: 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)
|
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
Periodo de tiempo: 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)
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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).
Periodo de tiempo: 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)
|
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)
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Need for postoperative vasopressor or respiratory support
Periodo de tiempo: Intraoperative through hospital discharge (about 2 to 3 days after surgery)
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Intraoperative through hospital discharge (about 2 to 3 days after surgery)
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Number of participants that need ICU admission
Periodo de tiempo: at hospital discharge (about 2 to 3 days after surgery)
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at hospital discharge (about 2 to 3 days after surgery)
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Length of hospital stay
Periodo de tiempo: at hospital discharge (about 2 to 3 days after surgery)
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at hospital discharge (about 2 to 3 days after surgery)
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Number of participants with postoperative hematoma
Periodo de tiempo: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Number of participants with surgical site infection
Periodo de tiempo: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Number of participants with wound complications
Periodo de tiempo: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Number of participants with peri-implant fracture or iatrogenic fracture
Periodo de tiempo: During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Stephen J Warner, MD, PhD, The University of Texas Health Science Center, Houston
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
21 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSC-MS-26-0228
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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