跳至主要内容
临床试验/CTRI/2017/08/009540
CTRI/2017/08/009540已完成不适用

A Prospective Analysis of MRI of fibrosis in post-operative TLIF Patients, Conventional Vs MISS

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
radiological . MRI parameters at work station.

研究概览

简要总结

This study is a randomized, prospective, single centre study analysing the radiological  MRI based changes of various muscle groups in the operative site in patients operated for single level lumbar or lumbosacral fusion surgery  one year prior to the study initiation time. The primary  outcome would be various MRI findings of fibrosis in posterior muscle groups for 2 years.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Single level Lumbar or lumbosacral fusion operated by conventional approach or MISS technique
  • Psychologically, mentally & physically able to fully comply with this protocol including adhering to completing forms & 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

  • Redo lumbar surgeries
  • Lumbar infection
  • Multilevel lumbar fusion
  • Lumbar laminectomy
  • Lumbar discectomy.

结局指标

主要结局

radiological . MRI parameters at work station.

时间窗: 2 years

次要结局

  • radiological . MRI parameters at work station.(2 years)

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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