跳至主要内容
临床试验/CTRI/2024/10/075894
CTRI/2024/10/075894尚未招募不适用

Diagnostic accuracy of pedicle screw placement using triggered electromyographic thresholds from stimulation over the pedicle screw compared to the stimulation within the pedicle hole.

Christian medical college Velloreranipet campus1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Additional method to affirm the proper placement of the pedicle screw inside the

研究概览

简要总结

The use of pedicle screws is a globally practised standard for all surgical treatments for spinal pathologies like deformity correction, degenerative disks, spondylolisthesis, etc. The risk is potential canal perforation resulting in irritation or compression of nerve roots. Malposition of PS can lead to structural instability and new onset motor or sensory deficits postoperatively. To decrease this risk, pedicle screw (PS) stimulation, an intraoperative neurophysiological monitoring (IONM) technique, was introduced to ascertain the proper placement of the PS into the pedicle hole along with other techniques like intraoperative fluoroscopy, direct inspection, and neuronavigation. Direct stimulation over the pedicle screw has been shown to have high specificity but clinically unacceptable low sensitivity. Hence, triggered electromyographic (t-EMG) cannot be solely relied upon for appropriate PS placement. However, using a stimulating probe inside the pedicle hole showed higher sensitivity than PS stimulation. In this study, we want to compare the diagnostic accuracy of pedicle hole stimulation with that of pedicle screw stimulation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adults posted for Lumbar posterior instrumentation with pedicle screw constructs for various pathologies at our institution over a 2-year period.
  • Pedicle screw instrumentation in L1 to S1 levels will be shortlisted.
  • The first 50 patients will be included.

排除标准

  • Dysmorphic pedicle features Pedicle screws other than T12 to S1.

结局指标

主要结局

Additional method to affirm the proper placement of the pedicle screw inside the

时间窗: 2-3 YEARS

spine bone.

时间窗: 2-3 YEARS

次要结局

  • EMG threshold values/sensitivity/specificity of pedicle hole stimulation & Pedicle screw stimulation.(at baseline)

研究者

发起方
Christian medical college Velloreranipet campus
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vasantha Kumar

Christian medical college Vellore-Ranipet campus

研究点 (1)

Loading locations...

相似试验

Is it better to stimulate inside the pedicle hole... | 临床试验