Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
569 participants
INTERVENTIONAL
2019-05-15
2022-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intraoperative Maneuvers
To document intraoperative maneuvers performed in repsonse to alerts
Document intraoperative Maneuvers
Monitoring procedure during surgery
Interventions
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Document intraoperative Maneuvers
Monitoring procedure during surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
80 Years
ALL
No
Sponsors
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AO Foundation, AO Spine
OTHER
Responsible Party
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Locations
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UC San Franciisco
San Francisco, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
Royal North Shore Hospital
Saint Leonards, , Australia
Hospital Infantil Joana de Gusmão
Florianópolis, , Brazil
Hospital das clinicas de São Paulo e AACD
São Paulo, , Brazil
Shriners Hospital for Children
Montreal, , Canada
Montreal General Hospital
Montreal, , Canada
Toronto Western Hospital
Toronto, , Canada
Nanjing Drum Tower Hospital
Nanjing, , China
Queen Mary Hospital
Hong Kong, , Hong Kong
Mallika Spine Centre
Guntur, , India
Kothari Medical Centre
Kolkata, , India
Tel Aviv Medical Center - Dana Children's Hospital
Tel Aviv, , Israel
Hamamatsu University School of Medicine
Hamamatsu, , Japan
University Medical Center St. Radboud
Nijmegen, , Netherlands
Ghurki Trust Teaching Hospital
Lahore, , Pakistan
Hospital Vall d'Helbron
Barcelona, , Spain
Acibadem Maslak Hospital
Istanbul, , Turkey (Türkiye)
Guys Hospital
London, , United Kingdom
Salford Royal Hospital
Manchester, , United Kingdom
Nottingham Queens Medical Centre
Nottingham, , United Kingdom
Countries
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Other Identifiers
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SDIM
Identifier Type: -
Identifier Source: org_study_id
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