Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03880292
Other study ID # SDIM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01220505 - Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Withdrawn NCT02058238 - ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Recruiting NCT05323448 - Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion. N/A
Recruiting NCT05108948 - Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
Completed NCT02950532 - Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Completed NCT01982045 - RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion N/A
Active, not recruiting NCT00738439 - Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Completed NCT05579834 - Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity
Completed NCT01608854 - Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains N/A
Active, not recruiting NCT04899297 - Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.
Completed NCT05239962 - A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.
Active, not recruiting NCT05001893 - Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
Completed NCT01601054 - Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity N/A
Active, not recruiting NCT04670536 - The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
Recruiting NCT05856370 - The Ailliance Post-Market Clinical Study N/A
Recruiting NCT05146193 - AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
Active, not recruiting NCT04642456 - Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity N/A
Recruiting NCT04071665 - A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis N/A
Completed NCT06009601 - The Relationship Between Pectus Deformities and Spinal Pathologies