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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
148
Using NeuroVision® prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
Using hospital based IONM prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGIncidence of new-onset neurological injury
Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)
Time frame: Enrollment up to 2 years postoperatively
Cost analysis of IONM use
Difference in costs of hospital IONM and Neurovision
Time frame: Enrollment up to 1 month post-operative
False positive and false negative events in each modality
Incorrect labeling of SSEP, tcMEP, and surface electromyography (sEMG) signals
Time frame: Intraoperatively up to 1 day post-operative
Adverse Events
Post-operative nausea and vomiting, Gastro-esophageal reflux, ileus, urinary tract infection, venous thromboembolic events, Respiratory depression/airway compromise,m renal insufficiency, wound complications
Time frame: Postoperative to documented progress assessed up to 2 months
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