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Neurologic Complications in Spinal Deformity Surgery

NCT01305343 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 273

Last updated 2015-12-24

No results posted yet for this study

Summary

240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention.

Regression analyses will be 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.

Conditions

  • Adult Spinal Deformity

Interventions

PROCEDURE

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
2011-08-31
Primary Completion
2014-11-30
Completion
2015-03-31

Countries

  • United States
  • Canada
  • China
  • Denmark
  • 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 NCT01305343 on ClinicalTrials.gov