NCT01741168

Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury

TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: The London Spine Centre · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.

Detailed description

The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.

Conditions

• Thoracolumbar Burst Fractures Without Neurologic Deficit

Interventions

Type	Name	Description
OTHER	TLSO	Patients in the TLSO arm will remain on bed rest until fitted with a TLSO. They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist.
OTHER	No Orthosis	Patients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk. They will be encouraged to return to normal activities after 8 weeks.

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-09-01
• Completion: 2011-09-01
• First posted: 2012-12-04
• Last updated: 2012-12-04

Locations

1 site across 1 country: Canada