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Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures

NCT01751633 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2020-08-13

No results posted yet for this study

Summary

Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.

Conditions

  • Single Level Stable Thoracolumbar Fracture Type AO A3
  • Multiple Level Stable Thoracolumbar Fracture Type AO A3

Interventions

PROCEDURE

Surgical

PROCEDURE

Conservative treatment

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Giuseppe Barbagallo, MD · Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy

  • Emiliano Vialle, MD · Catholic University of Parana - Curitiba, Brazil

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • Brazil
  • Chile
  • Czechia
  • Germany
  • Italy
  • Portugal

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 NCT01751633 on ClinicalTrials.gov