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NCT02949245

Neurologic Complications in Spinal Deformity Surgery - Extension

Completed Last updated 19 May 2020
What this trial tests

trial testing Interventions in Adult Spinal Deformity in 77 participants. Completed in 28 December 2019.

Timeline
17 August 2017
Primary endpoint
28 December 2019
28 December 2019

Quick facts

Lead sponsorAO Foundation, AO Spine
StatusCompleted
Study typeOBSERVATIONAL
Enrollment77
Start date17 August 2017
Primary completion28 December 2019
Estimated completion28 December 2019
Sites11 locations across Japan, United Kingdom, Canada, China, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

AO Foundation, AO Spine

Who can join

Adults 18 to 80, any sex, with Adult Spinal Deformity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits. Regression analyses were used to evaluate the association between patient demographics, co-morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery. All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.

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

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Other trials of Interventions

Trials testing the same drug.

Other recruiting trials for Adult Spinal Deformity

Currently open trials in the same condition.

Other AO Foundation, AO Spine trials

Trials by the same sponsor.

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Data sources for this page

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