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Spinal Deformity Intraoperative Monitoring.

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ClinicalTrials.gov Identifier: NCT03880292
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
AOSpine International

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Deformity Procedure: Document intraoperative Maneuvers Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Observational Study
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : July 1, 2022

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Intraoperative monitoring alert [ Time Frame: Intraoperative ]

    Intraoperative monitoring alerts:

    • Degree of change in the monitoring signals (SSEP, MEP, EMG)


  2. 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

  3. 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.


  4. Timing of intraoperative monitoring alerts [ Time Frame: Intraoperative ]
    Timing: Minutes since skin incision and minutes until recovery in MEP and SSEP



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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880292


Contacts
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Contact: Joffrey Baczkowski +41 44 200 24 31 joffrey.baczkowski@aofoundation.org
Contact: Katrin Simioni, PhD +41 44 200 24 31 katrin.simioni@aofoundation.org

Locations
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United States, California
UC San Franciisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Sigrud Berven, MD         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: David Polly, MD         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Lawernce Lenke, MD         
Australia
Royal North Shore Hospital Not yet recruiting
Saint Leonards, Australia, 2065
Contact: Randolph Gray, MD         
Brazil
Hospital Infantil Joana de Gusmão
Florianópolis, Brazil, 88025
Canada
Shriners Hospital for Children Not yet recruiting
Montréal, Canada, 124001
Contact: Jean Ouellet, MD         
Toronto Western Hospital Not yet recruiting
Toronto, Canada, M5T 2S8
Contact: Stephen J. Lewis, MD         
China
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, China, 210008
Contact: Yong Qiu, MD         
Hong Kong
Queen Mary Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: Kenny Kwan, MD         
India
Mallika Spine Centre Not yet recruiting
Guntur, India, 522001
Contact: J. Naresh-Babu, MD         
Kothari Medical Centre Not yet recruiting
Kolkata, India, 700027
Contact: Saumyjait Basu, MD         
Japan
Hamamatsu University School of Medicine Not yet recruiting
Hamamatsu, Japan
Contact: Go Yoshida, MD         
Pakistan
Ghurki Trust Teaching Hospital Not yet recruiting
Lahore, Pakistan
Contact: Amer Aziz, MD         
South Africa
Tygerberg Hospital Not yet recruiting
Kapstadt, South Africa, 7505
Contact: Sanesh Miseer, MD         
Spain
Hospital Vall d`Helbron Not yet recruiting
Barcelona, Spain, 08035
Contact: Kimia Rahnama-Zand, MD         
Turkey
Acibadem Maslak Hospital Not yet recruiting
Istanbul, Turkey, 34457
Contact: Ahmet Alanay, MD         
United Kingdom
Nottingham Queens Medical Centre Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Nasir Quraishi, MD         
Sponsors and Collaborators
AOSpine International

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Responsible Party: AOSpine International
ClinicalTrials.gov Identifier: NCT03880292     History of Changes
Other Study ID Numbers: SDIM
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Congenital Abnormalities