Spinal Deformity Intraoperative Monitoring.
Condition: Spinal Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      A multicenter, international prospectively collected patient cohort undergoing high-risk
      spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the
      incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors
      associated with mitigating injury. Baseline, intraoperative, and postoperative
      characteristics, including demographics, radiological features, lower extremity motor score
      (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for
      either adult patients or pediatric patients.
    

Detailed description: 
      A multicenter, international prospectively collected patient cohort undergoing high-risk
      spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the
      incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors
      associated with mitigating injury. Baseline, intraoperative, and postoperative
      characteristics, including demographics, radiological features, lower extremity motor score
      (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for
      either adult patients or pediatric patients.

      If a major change occurs in the intraoperative neuromonitoring, defined as a loss of
      amplitude greater than 50% in the MEP or SSEP from baseline or sustained EMG activity, a
      separate form (Appendix 3, Intraoperative Alert Form) will be completed in real-time by the
      neuromonitoring technician outlining the timing of the alert, blood pressure at the time,
      surgical events at the time of the change, intraoperative maneuvers performed to address the
      change, and resultant outcome of these maneuvers to address the neuromonitoring change. For
      each alert occurring during the procedure, a separate form will be completed.

      Once the patient is awake from anesthesia, the treating surgeon will perform a neurological
      examination to identify details about the deficit including sidedness, LEMS, sensory deficit,
      injury to the nerve root, incomplete spinal cord (ie anterior cord, posterior cord, central
      cord, Brown-Sequard), complete spinal cord injury, conus or cauda equina deficit. The
      examination is repeated on the day of discharge from hospital, or at day 30, whichever comes
      first and documented in the corresponding form.

      The objective of this study is to identify the incidence of intraoperative alerts in
      high-risk spinal cord cases, correlate significant neuromonitoring changes to intraoperative
      events, and identify maneuvers that will restore the neuromonitoring changes to baseline. The
      information provided by this study will educate spinal surgeons to recognize a spinal cord at
      risk and to perform intraoperative maneuvers that will decrease the incidence of neurological
      injuries.
    

Intervention name(s): Document intraoperative Maneuvers
Intervention type(s): Procedure
Intervention description(s): Monitoring procedure during surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic