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

Not Applicable

Completed

• Conditions: Thoracolumbar Burst Fractures Without Neurologic Deficit

• Registration Number: NCT01741168
• Lead Sponsor: The London Spine Centre

Brief 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.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2010-09
• Study Completion: 2011-09
• Status Verified: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-30
• Last Update Submitted: 2012-11-30
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• AO A3 burst fracture between T10 and L3 with associated kyphotic deformity <35 degrees
• neurologically intact or isolated nerve root deficit
• age 16-60 years
• enrollment within 3 days of injury

Exclusion Criteria

• neurological deficit
• can not comply with brace wearing (pregnancy/body mass index >40)
• mobilized with or without a brace prior to recruitment
• suffered a pathologic or open fracture
• alcohol or drug abusers
• had previous injury or surgery to the thoracolumbar region
• unable to complete the questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire	3 months post fracture	The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture. The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable. The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability). Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities.

Secondary Outcome Measures

Name	Time	Method
SF-36 physical component summary score	enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
SF-36 mental component summary score	enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
VAS pain score	enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Satisfaction with Treatment	enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months	Overall satisfaction with treatment was assessed on a seven point scale, using the sentence, "All things considered, how satisfied are you with the results of your recent treatment for your spine fracture?" This is a recommended tool for assessing global satisfaction.

Trial Locations

Locations (1)

London Spine Centre; 🇨🇦 London, Ontario, Canada