- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07655726
Intraoperative Analysis of Knee Kinematics During ACL Reconstruction - an Exploratory Study (CINEGEN)
Reconstruction of anterior cruciate ligament (ACL) is a common procedure in orthopaedic surgery, aimed at restoring stability to your knee. This procedure involves performing an anterior cruciate ligament (ACL) graft and an anterolateral ligament (ALL) graft.
Despite technological advances and improvements in surgical techniques, failure rates remain high. In this context, a better understanding of knee movements (the position of the femur and tibia, as well as the ligaments) during flexion whilst reconstructing your ACL could improve the precision of reconstructions and reduce the long-term failure rate.
Using a surgical navigation system, it is possible to record data on the positioning of the femur and tibia during flexion and extension. This type of morpho-functional analysis of knee kinematics during ACL reconstruction has never been carried out before.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Anterior cruciate ligament reconstruction is a common procedure in orthopaedic surgery, aimed at restoring knee stability following a ligament rupture. Despite technological advances and improvements in surgical techniques, failure rates remain a cause for concern.
There are many causes of ligament reconstruction failure, including biological factors (e.g. poor graft integration), repeated trauma and technical errors. Among the latter, poor tunnel positioning is the main cause, accounting for up to 29% of errors, the majority of which (75%) involve the femoral tunnel. Biomechanical studies have confirmed that inadequate positioning of the femoral tunnel alters knee kinematics, increasing stress on the graft and predisposing it to secondary rupture. In this context, a better understanding of intra-articular knee movements and the tension/relaxation profiles of the knee ligaments during flexion movements in surgery could improve the accuracy of reconstructions and reduce the long-term failure rate.
Using a surgical navigation system, it is possible to record data on the dynamic positioning of the femur and tibia during flexion and extension. MRI imaging also makes it possible to generate a digital twin of the patient's knee, including the patient's ligaments and their bony attachments. Aligning this digital twin with the positions of the femur and tibia recorded using intraoperative navigation makes it possible to determine, at different angles of flexion, the position of the digital twin and thus to measure the distance between the ligament insertions in the knee. This type of morpho-functional analysis of the 3D kinematics of the knee has not been published. This is why this research is initiated.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bertrand SONNERY-COTTET
- Número de teléfono: + 33 4 37 53 00 22
- Correo electrónico: sonnerycottet@aol.com
Ubicaciones de estudio
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Lyon, Francia, 69008
- Hôpital privé Jean Mermoz
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Contacto:
- Bertrand SONNERY-COTTET, MD
- Número de teléfono: + 33 4 37 53 00 22
- Correo electrónico: sonnerycottet@aol.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patient, male or female, aged between 18 and 40
- Patient eligible for ACL and LAL reconstruction
- Patient who is member of or covered by a social security scheme
- Patient who speaks French and has signed an informed consent form
Exclusion Criteria:
- Patient with a contraindication to MRI
- Patient with osteoarthritis of the joint
- Patient with a BMI > 30
- Patient with history of trauma or previous knee surgery
- Patient with knee trauma other than a sprain
- Patient under legal guardianship: an adult under guardianship, curatorship or other legal protection, or deprived of liberty by judicial or administrative order
- Pregnant or breastfeeding woman
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Knee cinematics
Intraoperative morpho-functional analysis of the injured knee
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The pins used for ACL reconstruction will serve as a mount for the optical markers used to record the position data of the femur and tibia during ACL reconstruction.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Knee cinematics
Periodo de tiempo: Day 0
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The kinematic changes in the knee resulting from ACL reconstruction in flexion (at 90° and 45°) and in extension will be assessed intraoperatively, based on the following distances measured before and after placement of the ACL graft:
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Day 0
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-A00868-43
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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