跳至主要内容
临床试验/NCT02886260
NCT02886260已完成不适用

Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2012年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
193
试验地点
2
主要终点
Quality of life measured by the Oswestry Disability Index score

研究概览

简要总结

This study aims to:

  1. describe the monitoring of patients treated for spinal disorders.
  2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.
  3. obtain a cohort of patients in the comprehensive range of spinal pathologies.
  4. standardize data collection in this cohort with similar national projects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient must be given free and informed consent and signed the consent
  • The patient must be affiliated or beneficiary of a health insurance plan
  • The patient is available for a 24-month follow-up
  • The patient is at least 18 years old
  • The patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment

排除标准

  • The patient is under judicial protection, guardianship or curatorship
  • The patient refuses to sign the consent
  • It is not possible to give informed information to the patient
  • The patient does not fluently read French.
  • the patient is not available for a 24-month follow-ip

结局指标

主要结局

Quality of life measured by the Oswestry Disability Index score

时间窗: 24 months after surgical intervention

次要结局

  • Quality of life measured by the Oswestry Disability Index score(6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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