Comparing NeuroVision to standard neuromonitoring during spinal surgery
NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial
This study is testing if a new monitoring system called NeuroVision can help prevent nerve injuries during spinal surgery better than the standard monitoring methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04639297 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of NeuroVision® intraoperative neuromonitoring (IONM) compared to conventional hospital-based IONM in patients undergoing lateral spinal surgery for degenerative conditions. Participants will be randomly assigned to receive either NeuroVision® IONM or standard IONM during their surgery. The study will assess the incidence of new-onset neurological injuries postoperatively, providing insights into the safety and efficacy of the NeuroVision® system. By utilizing real-time monitoring, the trial seeks to enhance surgical outcomes and minimize risks associated with spinal procedures.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for primary single or multilevel lateral spinal surgery due to degenerative conditions.
Not a fit: Patients with active infections, a history of malignancy, or recent spinal traumatic injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neurological outcomes for patients undergoing spinal surgery.
How similar studies have performed: Previous studies have shown promise in the use of intraoperative neuromonitoring, but the specific application of NeuroVision® is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Active infection * Active or history of malignancy * Spinal traumatic injury within the past 2 years
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.