跳至主要内容
临床试验/NCT03388307
NCT03388307Unknown不适用

Unilateral Decompression Approach for Lumbar Canal Stenosis

Assiut University0 个研究点目标入组 30 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
back pain

研究概览

简要总结

The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.

详细描述

Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord.

Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal .

The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes.

The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age:40-80 years
  • sex:both sexes
  • symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
  • radiologically confirmed LSS , caused by degenerative changes
  • canal stenosis at a maximum of 2 levels

排除标准

  • were to undergo a concomitant fusion or instrumentation placement;
  • had had previous lumbar surgeries at the same level;
  • had spondylolisthesis of any grade or degenerative scoliosis;
  • had evidence of instability on dynamic radiographs.

研究组 & 干预措施

unilateral laminotomy

Experimental

patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression

干预措施: unilateral laminotomy (Procedure)

decompressive laminectomy

Experimental

patients with lumbar canal stenosis who undergo decompressive laminectomy

干预措施: decompressive laminectomy (Procedure)

结局指标

主要结局

back pain

时间窗: one year

visual analog scale

次要结局

  • neurogenic claudication pain(one year)

研究者

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

ahmed esam mohamed

resident doctor of neurosurgery

Assiut University

相似试验

Unilateral Approach for Bilateral Decompression of... | 临床试验