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Spinal Deformity Intraoperative Monitoring.

NCT03880292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 569

Last updated 2022-11-21

No results posted yet for this study

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.

Conditions

  • Spinal Deformity

Interventions

PROCEDURE

Document intraoperative Maneuvers

Monitoring procedure during surgery

Sponsors & Collaborators

  • AO Foundation, AO Spine

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-03-31
Completion
2022-11-01

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • Hong Kong
  • India
  • Israel
  • Japan
  • Netherlands
  • Pakistan
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880292 on ClinicalTrials.gov