Clinical trial NCT03880292: Spinal Deformity Intraoperative Monitoring.
Official title: SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Deformity
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 569
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of intraoperative neuromontoring alerts
timeFrame: Intraoperative
Secondary outcomes:
measure: Intraoperative monitoring alert
timeFrame: Intraoperative
measure: Success rate of reversal maneuvers to restore signal above the threshold
timeFrame: Intraoperative
measure: Neurological status
timeFrame: Baseline up to 30 days postoperative
measure: Timing of intraoperative monitoring alerts
timeFrame: Intraoperative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UC San Franciisco
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
city: Florianópolis
country: Brazil
facility: Hospital Infantil Joana de Gusmão
city: São Paulo
country: Brazil
facility: Hospital das clinicas de São Paulo e AACD
city: Montréal
country: Canada
facility: Shriners Hospital for Children
city: Montréal
country: Canada
facility: Montreal General Hospital
city: Toronto
country: Canada
facility: Toronto Western Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Guntur
country: India
facility: Mallika Spine Centre
city: Kolkata
country: India
facility: Kothari Medical Centre
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center - Dana Children's Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
city: Lahore
country: Pakistan
facility: Ghurki Trust Teaching Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d'Helbron
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
city: London
country: United Kingdom
facility: Guys Hospital
city: Manchester
country: United Kingdom
facility: Salford Royal Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Queens Medical Centre
Study officials:
References: