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临床试验/NCT02254590
NCT02254590已完成不适用

Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression

Cairo University0 个研究点目标入组 104 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
主要终点
Oswestry Disability Index

研究概览

简要总结

To evaluate a new endoscopic technique for lumbar spinal canal decompression.

详细描述

104 consecutive patients suffering of neurogenic claudication were included in the study.

Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index [19] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit
  • Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included)
  • Failure of 3 months conservative treatment
  • Grade I degenerative spondylolisthesis and degenerative scoliosis

排除标准

  • Segmental Instability
  • Lytic Spondylolisthesis
  • 2- Predominant low back pain

结局指标

主要结局

Oswestry Disability Index

时间窗: 24 months

Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling

Modified Macnab criteria

时间窗: 24 months

patient satisfaction, the need for medications, ability to return to activity

次要结局

  • Time for ambulation(72 hours)
  • Time for hospitalization(72 hours)
  • VAS for back pain(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

hesham magdi soliman

Lecturer of Orthopedic Surgery

Cairo University

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