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Completed No phase listed Observational

Neurologic Complications in Spinal Deformity Surgery - Extension

ClinicalTrials.gov ID: NCT02949245

Public ClinicalTrials.gov record NCT02949245. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 8:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity (Scoli-RISK-1): A Prospective, Observational, Multi-center Study 5 Year Follow-up Extension

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02949245
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
AO Foundation, AO Spine
Other
Enrollment
77 participants

Conditions and interventions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 16, 2017
Primary completion
Dec 27, 2019
Completion
Dec 27, 2019
Last update posted
May 18, 2020

2017 – 2019

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
University of California San Francisco California 94118
Johns Hopkins University Baltimore Maryland 21205
Department of Orthopaedic Surgery, Washington University School of Medicine St Louis Missouri 63110
NYU School of Medicine New York New York 10023
University of Virginia Charlottesville Virginia 22903

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02949245, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 18, 2020 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02949245 live on ClinicalTrials.gov.

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