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COMPLETED
NCT03880292
NA

Spinal Deformity Intraoperative Monitoring.

Sponsor: AO Foundation, AO Spine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

10 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

592

Start Date

2019-05-15

Completion Date

2022-11-01

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

PROCEDURE

Document intraoperative Maneuvers

Monitoring procedure during surgery

Locations (24)

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