跳至主要内容
临床试验/NCT03856554
NCT03856554Unknown不适用

Comparison of Radiologic and Clinical Outcome of Single Level Lumbar Interbody Fusion Between Unilateral or Bilateral Facetectomy : Prospective Randomized Controlled Trial

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年7月6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
52
试验地点
1
主要终点
Sagittal balance

研究概览

简要总结

A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis

详细描述

Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - "Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate"

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

性别
All
接受健康志愿者

入选标准

  • lumbar degenerative spondylolisthesis
  • indicated for surgery

排除标准

  • not agreed for the study

研究组 & 干预措施

Patients indicated for TLIF

Experimental

Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

干预措施: Unilateral Transforaminal Interbody fusion (Procedure)

Patients indicated for TLIF

Experimental

Patients with lumbar degenerative spondylolisthesis, indicated for TLIF surgery

干预措施: Bilateral Transforaminal Interbody fusion (Procedure)

结局指标

主要结局

Sagittal balance

时间窗: through study completion, an average of 1 year

Radiologic parameters

Interbody fusion(union) failure

时间窗: through study completion, an average of 1 year

Radiologic parameters. Use dynamic plain X-ray. Union defined as no movement at segment

次要结局

  • Pain scores(through study completion, an average of 1 year)
  • Functional scores(through study completion, an average of 1 year)

研究者

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

Woo-Kie Min

Associate Professor, Spine Center and Department of Orthopedic Surgery

Kyungpook National University Hospital

研究点 (1)

Loading locations...

相似试验