Intraoperative Monitoring, Spinal Diseases
Conditions
Keywords
IOM, IONM, Intraoperative Monitoring, Intraoperative Neuromonitoring, Spine, Lumbar, Cervical
Brief summary
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.
Detailed description
Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM. Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.
Interventions
None listed
Sponsors
National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation
National Research Independent Operations Management
DC2 Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing lumbar or cervical surgery * Utilization of IOM * Understand and sign informed consent
Exclusion criteria
* There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Neurological Assessment at 24 hours | baseline and 24 hours from time of surgery | Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery |
| Change in Pain Intensity from Baseline at 24 hours | baseline and 24 hours from time of surgery | Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery |
| Complications | At time of surgery | — |
| Change from baseline in Neurological Assessment at 6 weeks | baseline and 6 weeks | Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks |
| Change in Pain Intensity from Baseline at 6 weeks | baseline and 6 weeks | Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks |
Countries
United States
Contacts
Primary ContactChristina R Cook, PhD
Backup ContactRisa Tyo, PharmD
Outcome results
None listed