跳至主要内容
临床试验/NL-OMON31834
NL-OMON31834已完成不适用

A randomised controlled trial, comparing Surgical Decompression with an Interspinous Implant in patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis. - The Felix trial

Paradigm Spine / InSpine0 个研究点目标入组 386 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
386

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • signed informed consent - is 45 - 80 years old at time of surgery - has intermittent neurogenic claudicatio - has received at least three months of conservative care therapy - has a regular indication for surgical intervention of INC - has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI - is physically and mentally willing and able to comply with the post-operative evaluations.

排除标准

  • - has cauda equina syndrome
  • - has Paget's disease, severe osteoporosis or metastasis to the vertebrae
  • - has significant scoliosis
  • - has a BMI > 40 kg/m2
  • - has had any surgery of the lumbar spine
  • - has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4)
  • - has significant instability of the lumbar spine
  • - has severe comorbid conditions
  • - has a fused segment at the indicated level

研究者

发起方
Paradigm Spine / InSpine

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