NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Incidence of new-onset neurological injury
研究概览
简要总结
The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.
详细描述
Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements.
Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes
- •Patients able to provide informed consent
排除标准
- •Active infection
- •Active or history of malignancy
- •Spinal traumatic injury within the past 2 years
研究组 & 干预措施
NeuroVision® IONM
Patients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of NeuroVision® IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms.
干预措施: NeuroVision® IONM (Device)
Conventional hospital based IONM
Patients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of hospital based IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms.
干预措施: Hospital Based IONM (Device)
结局指标
主要结局
Incidence of new-onset neurological injury
时间窗: Enrollment up to 2 years postoperatively
Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)
次要结局
- Adverse Events(Postoperative to documented progress assessed up to 2 months)
- Cost analysis of IONM use(Enrollment up to 1 month post-operative)
- False positive and false negative events in each modality(Intraoperatively up to 1 day post-operative)
研究者
Kern Singh, MD
Professor, Attending Physician
Rush University Medical Center