Spinal Deformity Intraoperative Monitoring.

November 17, 2022 updated by: AO Foundation, AO Spine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

569

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Saint Leonards, Australia, 2065
        • Royal North Shore Hospital
  • Brazil
      • Florianópolis, Brazil, 88025
        • Hospital Infantil Joana de Gusmão
      • São Paulo, Brazil
        • Hospital das clinicas de São Paulo e AACD
  • Canada
      • Montréal, Canada, 124001
        • Shriners Hospital for Children
      • Montréal, Canada
        • Montreal General Hospital
      • Toronto, Canada, M5T 2S8
        • Toronto Western Hospital
  • China
      • Nanjing, China, 210008
        • Nanjing Drum Tower hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • India
      • Guntur, India, 522001
        • Mallika Spine Centre
      • Kolkata, India, 700027
        • Kothari Medical Centre
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Medical Center - Dana Children's Hospital
  • Japan
      • Hamamatsu, Japan
        • Hamamatsu University School of Medicine
  • Netherlands
      • Nijmegen, Netherlands
        • University Medical Center St. Radboud
  • Pakistan
      • Lahore, Pakistan
        • Ghurki Trust Teaching Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Helbron
  • Turkey
      • Istanbul, Turkey, 34457
        • Acibadem Maslak Hospital
  • United Kingdom
      • London, United Kingdom
        • Guys Hospital
      • Manchester, United Kingdom
        • Salford Royal Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham Queens Medical Centre
  • United States
    • California
      • San Francisco, California, United States, 94143
        • UC San Franciisco
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intraoperative neuromontoring alerts
Time Frame: Intraoperative

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
Time Frame: Intraoperative

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
Time Frame: Intraoperative

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
Time Frame: Baseline up to 30 days postoperative

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
Time Frame: Intraoperative
Timing: Minutes since skin incision and minutes until recovery in MEP and SSEP
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Foundation, AO Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDIM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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