Thoracolumbar Burst Fractures Without Neurologic Deficit
Conditions
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.
Interventions
OTHERTLSO
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.
OTHERNo 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.
Sponsors
The London Spine Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed