Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department (SPINDATA)
2026年5月29日 更新者：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.
研究概览
详细说明
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
研究类型
介入性
注册 (估计的)
15000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Benjamin BOUYER, PROF
- 电话号码：+335 56 79 87 18
- 邮箱：b.bouyer@chu-bordeaux.fr
研究联系人备份
- 姓名：Ouidad BEN KACEM
- 电话号码：14 367 +335 56 79 87 18
- 邮箱：ouidad.hasnaoui@chu-bordeaux.fr
学习地点
-
-
-
Bordeaux、法国、33000
- 招聘中
- Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
-
接触：
- Ouidad BEN KACEM
- 电话号码：14 367 +335 56 79 87 18
- 邮箱：ouidad.hasnaoui@chu-bordeaux.fr
-
接触：
- Benjamin BOUYER, MD
- 电话号码：+335 56 79 87 18
- 邮箱：b.bouyer@chu-bordeaux.fr
-
首席研究员：
- Benjamin BOUYER, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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)
|
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)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recourse to surgery
大体时间：Inclusion visit
|
Rate of recourse to surgery by type of spinal pathology given (cervical, thoracic or lumbar degenerative or spinal deformity).
|
Inclusion visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical characteristics
大体时间：Inclusion visit, Visit Month 24 and Visit Month 36
|
Weight of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Socio-demographic
大体时间：Inclusion visit, Visit Month 24 and Visit Month 36
|
Socio-demographic characteristics (occupation)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Socio-demographic
大体时间：Inclusion visit, Visit Month 24 and Visit Month 36
|
Socio-demographic characteristics (sports activities)
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Questionnaire of Quality of life
大体时间：Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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
|
|
Questionnaire of Quality of life
大体时间：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
|
|
Lower back pain.
大体时间：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
|
|
Cervical pain
大体时间：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.
大体时间：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.
大体时间：Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
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
|
|
Clinical characteristics
大体时间：Inclusion visit, Visit Month 24 and Visit Month 36
|
Body Mass Index of patient
|
Inclusion visit, Visit Month 24 and Visit Month 36
|
|
Evaluation of the safety of care provided.
大体时间：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
|
|
Evaluation of the safety of care provided.
大体时间：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 site infections
|
Inclusion visit, Month 3, Month 6, Month 12, Month 24 and Month 36 visits
|
|
Evaluation of the safety of care provided.
大体时间：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
|
|
Evaluation of the safety of care provided.
大体时间：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.
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Benjamin BOUYER, PROF、University Hospital, Bordeaux
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年5月25日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2031年8月1日
研究注册日期
首次提交
2026年3月5日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.