Spinal Deformity Intraoperative Monitoring.

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880292
• Other study ID #: SDIM
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: AO Foundation, AO Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: November 1, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Intervention

Procedure:
• Document intraoperative Maneuvers
Monitoring procedure during surgery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AO Foundation, AO Spine

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Hong Kong,  India,  Israel,  Japan,  Netherlands,  Pakistan,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intraoperative neuromontoring alerts	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	Intraoperative monitoring alert	Intraoperative monitoring alerts: • Degree of change in the monitoring signals (SSEP, MEP, EMG)	Intraoperative
Secondary	Success rate of reversal maneuvers to restore signal above the threshold	Number and type of maneuver(s) in response to an alert; number and type of successful maneuvers; number and type of unsuccessful maneuvers	Intraoperative
Secondary	Neurological status	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
Secondary	Timing of intraoperative monitoring alerts	Timing: Minutes since skin incision and minutes until recovery in MEP and SSEP	Intraoperative