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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thoracolumbar Burst Fractures Without Neurologic Deficit

Intervention / Treatment
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* Other: TLSO
* Other: No Orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TLSO<br>TLSO brace 8-10 weeks | Other: TLSO<br>* 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.<br>* Other names: TLSO Aspen Medical Products, Irvine, CA, USA;|
| Experimental: No Orthosis<br>No Orthosis | Other: No Orthosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire | 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. | 3 months post fracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months |