Thoracolumbar Burst Fractures Without Neurologic Deficit Clinical Trial
Official title:
TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
| Verified date | November 2012 |
| Source | The London Spine Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 97 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | London Spine Centre | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The London Spine Centre |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | SF-36 physical component summary score | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years | No | |
| Secondary | SF-36 mental component summary score | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | No | |
| Secondary | VAS pain score | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | No | |
| Secondary | 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 | No |