Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: self-administered questionnaire.
- Кому может быть актуально
- Состояния в реестре: Spinal Stenosis, SPINAL Fracture, Vertebral Osteomyelitis, Vertebral Metastasis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of the Evolution of the Quality of Life of Patients Treated by the Spinal Pathology Department
Обзор
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.
Подробное описание
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
Вмешательства
- Диагностический тест self-administered questionnaire
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)
Первичные конечные точки
- Recourse to surgery [Срок оценки: Inclusion visit]
Вторичные конечные точки (12)
- Clinical characteristics [Срок оценки: Inclusion visit, Visit Month 24 and Visit Month 36]
- Socio-demographic [Срок оценки: Inclusion visit, Visit Month 24 and Visit Month 36]
- Socio-demographic [Срок оценки: Inclusion visit, Visit Month 24 and Visit Month 36]
- Questionnaire of Quality of life [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Questionnaire of Quality of life [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Lower back pain. [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Cervical pain [Срок оценки: 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. [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Evaluation of the safety of care provided. [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Clinical characteristics [Срок оценки: Inclusion visit, Visit Month 24 and Visit Month 36]
- Evaluation of the safety of care provided. [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
- Evaluation of the safety of care provided. [Срок оценки: Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Франция · 1 центр
- Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux — Bordeaux
Идентификаторы
NCT: NCT07627282 · CHUBX 2022/58