Spinal Deformity Intraoperative Monitoring.

  • STATUS
    Recruiting
  • End date
    Jul 1, 2022
  • participants needed
    550
  • sponsor
    AO Foundation, AO Spine
Updated on 4 June 2021
spondylolisthesis
spinal cord
alerts
radiculopathy

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.

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.

Details
Condition Spinal Deformity
Treatment Document intraoperative Maneuvers
Clinical Study IdentifierNCT03880292
SponsorAO Foundation, AO Spine
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

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
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