跳至主要内容
临床试验/CTRI/2021/04/032957
CTRI/2021/04/032957招募中不适用

An Observational retrospective & prospective analysis of use, advantages, disadvantages & significance of intraoperative neuromonitoring in spine surgeries.

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Single time Evaluation of significance, advantages & disadvantages of IONM (Intraoperative Neuromonitoring) specifically in spine surgery in our tertiary care set up.

研究概览

简要总结

This is a single center, retrospectively& prospectively analytic study. Patientswill be evaluated in follow-up visit overtime to know if patient recoveredreally in follow up times.

A total minimum of 200 (All previousoperated and coming two years data) patients who meet the inclusion / exclusioncriteria will be enrolled in the study.

The total duration of this study isexpected to be up to 12-24 months.

During the study IONM dataof patients operated for various spinal surgery with the help of IONM will beassessed and analyzed. In this study advantages & disadvantages of the useof IONM in spine surgeries will be assessed. Factors affecting specificity& accuracy will be ruled out.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Any Patient operated any spine surgery using IONM.
  • Age: 1 to 90 Years 3)Patient willing to give consent and participate in the study 4)Psychosocially, mentally and physically able to fully comply with this protocol in-cluding adhering to completing forms and other study procedures.
  • Personally, signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.

排除标准

  • 1.Any patient operated without using IONM.
  • 2.Patient not willing to participate in the study or not willing to sign the consent form.

结局指标

主要结局

Single time Evaluation of significance, advantages & disadvantages of IONM (Intraoperative Neuromonitoring) specifically in spine surgery in our tertiary care set up.

时间窗: 2 Years

次要结局

  • Factors affecting specificity & accuracy will be ruled out.

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

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