- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07574775
Is It Possible to Obtain Reliable MPTA and LDFA Values Using Imageless Navigation in Total Knee Arthroplasty? Comparison Between Preoperative CT Scan Measurements and Intraoperative Bone Morphing Before and After Articular Cartilage Removal (CAR-NAV-AL)
Is It Possible to Obtain Reliable MPTA and LDFA Values Using Imageless Navigation in Total Knee Arthroplasty? Comparison Between Preoperative CT Scan Measurements and Intraoperative Bone Morphing Before and After Articular Cartilage Removal.
Title: Evaluation of Image-less Navigation Accuracy in Total Knee Arthroplasty (CARNAVAL)
Summary:
The purpose of this study is to evaluate the accuracy of an imageless navigation system in measuring key anatomical angles (MPTA and LDFA) during Total Knee Arthroplasty (TKA). While preoperative CT scans are currently the gold standard for bone planning, imageless navigation uses a "bone morphing" technique during surgery to create a digital model of the knee.
The study aims to determine if the measurements obtained via bone morphing, both before and after cartilage removal, are consistent with the measurements obtained from preoperative CT scans. The investigators seek to confirm if imageless navigation can provide reliable anatomical data, potentially reducing the need for preoperative radiation and costs associated with CT imaging.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Accurate alignment is critical for the long-term success of Total Knee Arthroplasty (TKA). Newer robotic and navigated systems rely on bone morphing to define the patient's anatomy per-operatively. However, the impact of cartilage thickness and the intrinsic accuracy of these systems compared to 3D CT-based planning remain subjects of clinical interest.
Objectives:
The primary objective is to compare the Medial Proximal Tibial Angle (MPTA) and the Lateral Distal Femoral Angle (LDFA) measured by:
Preoperative CT scan (Reference standard).
Peroperative image-less navigation (bone morphing) with intact cartilage.
Peroperative image-less navigation (bone morphing) after cartilage removal.
Methodology:
This is a prospective, monocentric, interventional study. All included patients will undergo a standard preoperative 3D CT scan as part of the surgical planning. During the TKA procedure, the surgeon will use the navigation system to perform bone morphing at two specific stages:
Initial stage: On the joint surface with the cartilage still present.
Secondary stage: After the surgical removal of the articular cartilage.
Comparison:
The data collected peroperatively will be compared to the CT scan measurements. The study will evaluate the "fidelity" (accuracy) of the navigation system and analyze whether the presence or absence of cartilage significantly alters the reliability of the digital bone model created by the system.
Expected Outcomes:
The results will help determine the degree of confidence surgeons can place in imageless navigation for achieving precise anatomical alignment without the systematic use of preoperative 3D imaging.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Paris, Francia, 75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients aged 18 years or older.
Patients with primary or secondary knee osteoarthritis requiring a Total Knee Arthroplasty (TKA).
Patients for whom the surgical planning requires a pre-operative 3D CT scan.
Patients who have been informed about the study and have signed the written informed consent.
Patients affiliated with or beneficiaries of a social security scheme.
Exclusion Criteria:
Revision Total Knee Arthroplasty (re-operation).
Major bone loss or significant bone deformity that prevents reliable anatomical landmarking.
History of prior knee surgery that could interfere with the navigation system trackers (e.g., retained hardware in the femur or tibia).
Pregnant or breastfeeding women.
Persons deprived of liberty or under legal guardianship.
Patients with a known allergy to any component used during the standard surgical procedure.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Navigation and CT-scan Comparison Group)
All participants undergo Total Knee Arthroplasty (TKA) using an imageless navigation system.
Anatomical measurements (MPTA and LDFA) are recorded via bone morphing at two stages: 1) on intact articular cartilage and 2) after cartilage removal.
|
Intraoperative surface morphing of the joint surfaces is performed to obtain LDFA and MPTA values.
The procedure compares measurements taken on the residual cartilage versus measurements taken directly on the osseous surface after cartilage debridement.
These values are then validated against preoperative 3D CT scan data.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation.
Periodo de tiempo: At the time of surgery (intra-operative).
|
The mean difference (measured in degrees) between the MPTA calculated from the preoperative 3D CT scan and the MPTA measured intraoperatively via bone morphing after cartilage removal.
|
At the time of surgery (intra-operative).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Difference in Lateral Distal Femoral Angle (LDFA) between CT scan and Imageless Navigation.
Periodo de tiempo: At the time of surgery (intraoperative)
|
The mean difference (measured in degrees) between the LDFA calculated from the preoperative 3D CT scan and the LDFA measured intraoperatively via bone morphing after cartilage removal.
|
At the time of surgery (intraoperative)
|
|
Correlation of MPTA and LDFA measurements before and after cartilage removal.
Periodo de tiempo: At the time of surgery (intra-operative).
|
Evaluation of the measurement shift (in degrees) caused by the presence of articular cartilage during the bone morphing process.
This assesses the system's ability to extrapolate the subchondral bone surface.
|
At the time of surgery (intra-operative).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Antoine MOUTON, Orthopedic surgeon, Diaconesses Croix Saint Simon Hospital Group
Publicaciones y enlaces útiles
Publicaciones Generales
- MacDessi SJ, Griffiths-Jones W, Harris IA, Bellemans J, Chen DB. Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J. 2021 Feb;103-B(2):329-337. doi: 10.1302/0301-620X.103B2.BJJ-2020-1050.R1.
- Blakeney WG, Khan RJ, Wall SJ. Computer-assisted techniques versus conventional guides for component alignment in total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011 Aug 3;93(15):1377-84. doi: 10.2106/JBJS.I.01321.
- Rossi SMP, Sangaletti R, Perticarini L, Terragnoli F, Benazzo F. High accuracy of a new robotically assisted technique for total knee arthroplasty: an in vivo study. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):1153-1161. doi: 10.1007/s00167-021-06800-8. Epub 2022 Jan 4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 2025-A00825-44
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .