Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis (CARTILAGE)
Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Knee osteoarthritis (OA) is a common degenerative disease of synovial joint becoming more frequent with age. Among techniques have been used to diagnose and classify the severity of knee OA, the imaging techniques, such as ultrasonography (US), provide physical quantitative informations for better understanding and assessing of the pathology of the knee joint.
The present study aim to investigate the diagnostic performance of ultrasonography for femoral condyle cartilage evaluation using MRI and histology analysis as reference tools. To validate this approach, evaluations are conducted to determine, whether the UltraSound Speed Of Sound (US-SOS) propagation is associated with the variation of the arthrosis stage, in order to improve the diagnosis of the surgeon. For this purpose, measurements are conducted using selected human cartilage samples with different stage of OA (early stage and advanced stage).
This research is the first "preclinical" study of a new unlabelled medical device developed by Cartimage Medical SAS. Cartilage is a prospective, monocentric, unrandomized and uncontrolled study. This study doesn't modify the medical care of the patient.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Grenoble, Francia, 38043
- Orthopedic Surgery Department, University Hospital, Grenoble
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- patient over 18 year old
- knee osteoarthritis which total knee arthroplasty indication
- who have signed a non-objection form.
Exclusion Criteria:
- person who refuse to sign a non-objection form
- person deprived of liberty by judicial or administrative decision
- person under legal protection or unable to express their consent
- person hospitalized for psychiatric care
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Ultrasound assessment
All subject of the study have a knee osteoarthritis (OA) and are going to have a total arthroplasty.
Diagnostic performance of ultrasonography is evaluated on ex vivo cartilage samples (2 samples per patient are selected with different stage of OA : 1 with early stage and 1 with advanced stage).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluation of the correlation between the Time of Flight (TOF) of ultrasounds between the two interfaces (bone / cartilage and cartilage / water) and the real thickness of the cartilage measured by Magnetic Resonance Imaging (MRI).
Periodo de tiempo: 5 months
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Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.
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5 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.
Periodo de tiempo: 5 months
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Correlation coefficients between the US propagation velocity measurements and OA progression according to the seven groups of the OARSI scale. Position indicators of US propagation velocity measurements of the 2 groups "early stage" (0 <= OARSI <= 2) and "advanced stage" (3 <= OARSI <= 6). |
5 months
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Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data
Periodo de tiempo: 5 months
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Correlation coefficient between surface area of samples and defects estimated from ultrasound data and those derived from MRI data. Correlation coefficients between surface volumes of samples and defects estimated from ultrasound data and those derived from MRI data. |
5 months
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Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.
Periodo de tiempo: 5 months
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Correlation coefficients between thickness measurements estimated from MRI data and those estimated from histological data.
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5 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alexandre Moreau -Gaudry, MD, PhD, Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble
Publicaciones y enlaces útiles
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
- 38RC17.074
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.
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