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Neurologic Complications in Spinal Deformity Surgery - Extension

NCT02949245 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2020-05-19

No results posted yet for this study

Summary

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.

Conditions

  • Adult Spinal Deformity

Interventions

PROCEDURE

Interventions

Procedure/Surgery: Routinely performed surgical correction of spinal deformity Routinely performed surgical correction of spinal deformity

Sponsors & Collaborators

  • Scoliosis Research Society

    collaborator OTHER

  • AO Foundation, AO Spine

    lead OTHER

Principal Investigators

  • Lawrence Lenke, MD · Scoliosis Research Society

Eligibility

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

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2019-12-28
Completion
2019-12-28

Countries

  • United States
  • Canada
  • China
  • Japan
  • Spain
  • 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 NCT02949245 on ClinicalTrials.gov