Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department (SPINDATA)
29 de mayo de 2026 actualizado por: University Hospital, Bordeaux
Evaluation of the Evolution of the Quality of Life of Patients Treated by the Spinal Pathology Department
Spinal conditions are a major public health issue.
Their management by surgical treatment is constantly improving and surgical procedures or implantable medical devices are experiencing significant progress.
These innovations have not yet all been precisely evaluated but have already led to significant changes in care practices.
The primary objective of our study is to describe, via an exhaustive collection of data, the quarterly evolution over 5 years of practices in the management of spinal pathologies.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
The team will conduct a monocentric (department of spine surgery, University Hospital of Bordeaux, France) prospective observational study during 5 years, involving all patients treated for a spinal condition (including degenerative pathology of the lumbar, thoracic or cervical spine, deformities of the spine and for the traumatic, infectious and tumor pathologies).The data collected will concern the general condition of the patients, their reasons for consultation, the details of their spinal pathology and its impact using specific functional assessment self-questionnaires, as well as the care provided.
A three years follow-up will be planned
Tipo de estudio
Intervencionista
Inscripción (Estimado)
15000
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: Benjamin BOUYER, PROF
- Número de teléfono: +335 56 79 87 18
- Correo electrónico: b.bouyer@chu-bordeaux.fr
Copia de seguridad de contactos de estudio
- Nombre: Ouidad BEN KACEM
- Número de teléfono: 14 367 +335 56 79 87 18
- Correo electrónico: ouidad.hasnaoui@chu-bordeaux.fr
Ubicaciones de estudio
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-
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Bordeaux, Francia, 33000
- Reclutamiento
- Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
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Contacto:
- Ouidad BEN KACEM
- Número de teléfono: 14 367 +335 56 79 87 18
- Correo electrónico: ouidad.hasnaoui@chu-bordeaux.fr
-
Contacto:
- Benjamin BOUYER, MD
- Número de teléfono: +335 56 79 87 18
- Correo electrónico: b.bouyer@chu-bordeaux.fr
-
Investigador principal:
- Benjamin BOUYER, MD
-
-
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:
- Patient > 18 years old
- Minor patient, able to accept the data collection, with the consent of the holder(s)
- Patient consulting for a medical reason involving a spinal pathology in the investigating center (spinal surgery department): Degenerative pathology of the thoracic or lumbar spine; Degenerative pathology of the cervical spine; Deformation of the spine; Urgent traumatic, infectious and tumor pathologies.
Exclusion criteria:
- Patient under guardianship or curators,
- Persons deprived of liberty by judicial or administrative decision,
- Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
- Persons unable to express their consent,
- Persons under legal protection,
- Patient not affiliated to a social protection scheme.
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: Otro
- 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: Patient consulting in spine surgery
quality of life scales for all patient consulting in spine surgery unit and psychological rating scales only for patients who require it (determined by the surgeon)
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quality of life scales for all patient consulting in spine surgery unit and psychological rating scales only for patients who require it (determined by the surgeon)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recourse to surgery
Periodo de tiempo: Inclusion visit
|
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
|
Inclusion visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical characteristics
Periodo de tiempo: Inclusion visit, Visit Month 24 and Visit Month 36
|
Weight of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
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Socio-demographic
Periodo de tiempo: Inclusion visit, Visit Month 24 and Visit Month 36
|
Socio-demographic characteristics (occupation)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
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Socio-demographic
Periodo de tiempo: Inclusion visit, Visit Month 24 and Visit Month 36
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Socio-demographic characteristics (sports activities)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
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Questionnaire of Quality of life
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
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Health-related quality of life evaluated using the SF-36 questionnaire.
This questionnaire is composed of 11 items and total score from 0 to 100
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Questionnaire of Quality of life
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
Health-related quality of life evaluated using the EQ-5D-5L questionnaire.
This questionnaire is composed of 5 items and total score from 5 to 25
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Lower back pain.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
The ODI (Oswestry Disability Index) score is used to measure the degree of disability related to lower back pain. The questionnaire contains 10 items, each scored from 0 to 5 points. The maximum total score is 50 points. |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Cervical pain
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
The NDI is used to measure disability related to cervical pain via a standardized questionnaire. The questionnaire contains 10 items, each scored from 0 to 5 points. The maximum total score is 50 points. The higher the percentage, the greater the functional impairment. |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Cervical function, Upper limb function, Lower limb function, Bladder function, Quality of life.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
The JOACMEQ (Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire) provides 5 independent scores (0-100): Cervical function, Upper limb function, Lower limb function, Bladder function, Quality of life. Each area gives a score between 0 (worst) and 100 (best condition). |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Evaluation of the safety of care provided.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
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For each type of spinal pathology, measurement of: - Incidence of serious medical complications |
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Clinical characteristics
Periodo de tiempo: Inclusion visit, Visit Month 24 and Visit Month 36
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Body Mass Index of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
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Evaluation of the safety of care provided.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
For each type of spinal pathology, measurement of Incidence of mortality, assessed by recalling patients lost to follow-up
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Evaluation of the safety of care provided.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
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For each type of spinal pathology, measurement of Incidence of surgical site infections
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Evaluation of the safety of care provided.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
For each type of spinal pathology, measurement of Incidence of mechanical complications
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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Evaluation of the safety of care provided.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
For each type of spinal pathology, measurement of Incidence of neurological complications
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Evaluation of the safety of care provided.
Periodo de tiempo: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
For each type of spinal pathology, measurement of Incidence of surgical re-interventions
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Benjamin BOUYER, PROF, University Hospital, Bordeaux
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 (Actual)
25 de mayo de 2023
Finalización primaria (Estimado)
1 de agosto de 2028
Finalización del estudio (Estimado)
1 de agosto de 2031
Fechas de registro del estudio
Enviado por primera vez
5 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHUBX 2022/58
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
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