MedTrace Logo

Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

NCT02827214 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 213

Last updated 2023-01-31

No results posted yet for this study

Summary

Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.

Conditions

  • Thoracolumbar Burst Fracture

Sponsors & Collaborators

  • AO Foundation, AO Spine

    collaborator OTHER

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Marcel Dvorak, MD · Vancouver General Hospital

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States
  • Australia
  • Canada
  • Egypt
  • Greece
  • India
  • Netherlands
  • Romania
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT02827214 on ClinicalTrials.gov