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.
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.
Study Type
OBSERVATIONAL
Enrollment
10,000
DC2 Healthcare
Nashville, Tennessee, United States
RECRUITINGChange from baseline in Neurological Assessment at 24 hours
Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery
Time frame: baseline and 24 hours from time of surgery
Change in Pain Intensity from Baseline at 24 hours
Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery
Time frame: baseline and 24 hours from time of surgery
Complications
Time frame: At time of surgery
Change from baseline in Neurological Assessment at 6 weeks
Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks
Time frame: baseline and 6 weeks
Change in Pain Intensity from Baseline at 6 weeks
Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks
Time frame: baseline and 6 weeks
Complications
Time frame: 24 hours after surgery
Complications
within 6 weeks after surgery but not less than 4 weeks
Time frame: 6 weeks after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.