NCT03880292

Spinal Deformity Intraoperative Monitoring.

Completed NA Last updated 21 November 2022

What this trial tests

NA trial testing Document intraoperative Maneuvers in Spinal Deformity in 569 participants. Completed in 1 November 2022.

Timeline

15 May 2019

Primary endpoint
31 March 2022

1 November 2022

Quick facts

Lead sponsor	AO Foundation, AO Spine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	569
Start date	15 May 2019
Primary completion	31 March 2022
Estimated completion	1 November 2022
Sites	24 locations across Hong Kong, Pakistan, Japan, Netherlands, United Kingdom, Israel, Canada, Australia

Drugs / interventions tested

• Document intraoperative Maneuvers

Conditions studied

• Spinal Deformity — all drugs for Spinal Deformity →

Sponsor

AO Foundation, AO Spine

Who can join

Adults 10 to 80, any sex, with Spinal Deformity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The AO Spine Knowledge Forums: A Decade of Impactful Spine Research.
   Schnake KJ, Fehlings MG, Germscheid N, Kurpad S, et al · · 2025 · PMID 40484860 · DOI 10.1177/21925682251343521