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- Ensayo clínico NCT01832272
Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
18 de mayo de 2014 actualizado por: Tae Kyun Kim, Seoul National University Hospital
The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation.
The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet.
However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc.
Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased.
This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time.
On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time.
The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release.
The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again.
However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature.
Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
174
Fase
- Fase 4
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: Tae Kyun Kim, MD, PhD
- Número de teléfono: 82-31-787-7196
- Correo electrónico: osktk@snubh.org
Ubicaciones de estudio
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Gyeonggi-do
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Seongnam-Si, Gyeonggi-do, Corea, república de, 463-707
- Reclutamiento
- Joint Reconstruction Center, Seoul National University Bundang Hospital
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Contacto:
- Tae Kyun Kim, MD, PhD
- Número de teléfono: 82-31-787-7196
- Correo electrónico: osktk@snubh.org
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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
40 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of primary osteoarthritis of the knee
- Scheduled for elective total knee arthroplasty
- Written signed consent
Exclusion Criteria:
- Revision TKA
- Diagnosis other than primary osteoarthritis
- Intra-articular indwelling drainage
- Refusing participate
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Reinflation after early deflation
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).
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The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Otros nombres:
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Sin intervención: No reinflation after early deflation
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Operation time
Periodo de tiempo: from skin incision to wound closure
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Total time between initial skin incision and wound closure
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from skin incision to wound closure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tourniquet time
Periodo de tiempo: total sum of time between inflation and deflation of tourniquet
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Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
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total sum of time between inflation and deflation of tourniquet
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Difficulty of the operation
Periodo de tiempo: from skin incision to wound closure
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Measured by the number of operative field clearance using gauze to make the remained procedure convenient
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from skin incision to wound closure
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Incidence of transfusion
Periodo de tiempo: within 2weeks after surgery
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The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
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within 2weeks after surgery
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Wound complications
Periodo de tiempo: on the 2nd and 14th day after surgery
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wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
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on the 2nd and 14th day after surgery
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Thigh complications
Periodo de tiempo: within 2 weeks
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Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
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within 2 weeks
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Venous thromboembolism
Periodo de tiempo: within 2 weeks
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symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
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within 2 weeks
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Postoperative pain (VAS)
Periodo de tiempo: on the 2nd and 5th day after surgery.
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An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
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on the 2nd and 5th day after surgery.
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More painful site
Periodo de tiempo: on the 2nd and 5th day after surgery
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An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
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on the 2nd and 5th day after surgery
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More painful side in SBTKA
Periodo de tiempo: on the 2nd and 5th day after surgery.
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An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
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on the 2nd and 5th day after surgery.
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Amount of drainage
Periodo de tiempo: Until the drainage removal, average of 1 to 2 days after surgery
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Total amount of subcutaneous indwelled drainage before removal of it.
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Until the drainage removal, average of 1 to 2 days after surgery
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Hemoglobin drop on the 2nd day after surgery
Periodo de tiempo: On the 2nd day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
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On the 2nd day after surgery
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Hemoglobin drop on the 5th day after surgery
Periodo de tiempo: On the 5th day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
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On the 5th day after surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tae Kyun Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital
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
1 de febrero de 2013
Finalización primaria (Anticipado)
1 de diciembre de 2014
Finalización del estudio (Anticipado)
1 de enero de 2015
Fechas de registro del estudio
Enviado por primera vez
20 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
15 de abril de 2013
Publicado por primera vez (Estimar)
16 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B-1206/158-004
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