Spinal Deformity Intraoperative Monitoring.

Study Overview
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Brief Summary
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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
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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.

Official Title
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SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Interventional Study

Conditions
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Spinal Deformity

Intervention / Treatment
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* Procedure: Document intraoperative Maneuvers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >10 years to <80 years Neurologically intact spinal cord (with or without radiculopathy) Undergoing primary or revision procedure in the spine Anterior and/or posterior surgical approach for any of the following: Correction of spinal deformity with a major Cobb angle of ≥ 80° in the coronal or sagittal plane Correction of high grade spondylolisthesis (Grades 3- 5) Posterior column or 3-column osteotomy Requiring multimodal neuromonitoring with EMG, SSEP, and MEP as per standard of care Informed consent obtained for patients i.e.: Ability to understand the content of the patient information Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP) Signed and dated EC/IRB approved written informed consent OR Written consent obtained according to defined and IRB/EC approved procedures for patients who are not able to provide independent written informed consent Exclusion Criteria: • Neurodegenerative disease Upper motor neuron lesion Growing rods or growth guidance procedures Tether or staple procedures Stand-alone cervical deformity correction procedures Any not medically managed severe systemic disease Recent history of substance abuse (ie recreational drugs, alcohol) that would preclude reliable assessment Pregnancy or women planning to conceive within the study period Prisoner Participation in any other medical device or medicinal product study that could influence the results of the present study

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intraoperative Maneuvers<br>To document intraoperative maneuvers performed in repsonse to alerts | Procedure: Document intraoperative Maneuvers<br>* Monitoring procedure during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intraoperative neuromontoring alerts | Number of intraoperative neuromonitoring alert, defined as a major change in neuromonitoring signals: SSEP: amplitude loss > 50% MEP: amplitude loss > 50% in two of three muscle groups and/or EMG: sustained activity for > 10 seconds | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative monitoring alert | Intraoperative monitoring alerts: • Degree of change in the monitoring signals (SSEP, MEP, EMG) | Intraoperative | 
| Success rate of reversal maneuvers to restore signal above the threshold | Number and type of maneuver(s) in response to an alert number and type of successful maneuvers number and type of unsuccessful maneuvers | Intraoperative | 
| Neurological status | Neurological status: • ASIA Lower extremity motor and sensory score including if a spinal cord syndrome is applicable. A scale from 0 to 5 points in which 0 denotes total paralysis and 5 normal active movement. Sensory will be meassured as either normal, altered or absent. | Baseline up to 30 days postoperative | 
| Timing of intraoperative monitoring alerts | Timing: Minutes since skin incision and minutes until recovery in MEP and SSEP | Intraoperative |