Diagnostic accuracy of pedicle screw placement using triggered electromyographic thresholds from stimulation over the pedicle screw compared to the stimulation within the pedicle hole.
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
Dr Vasantha Kumar
Christian medical college Vellore-Ranipet campus
