Back to resultsBrace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
Primary Purpose
Thoracolumbar Burst Fractures Without Neurologic Deficit
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TLSO
No Orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Thoracolumbar Burst Fractures Without Neurologic Deficit
Eligibility Criteria
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
Sites / Locations
- London Spine Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TLSO
No Orthosis
Arm Description
TLSO brace 8-10 weeks
No Orthosis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
SF-36 physical component summary score
SF-36 mental component summary score
VAS pain score
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.
Full Information
NCT ID
NCT01741168
First Posted
November 22, 2012
Last Updated
November 30, 2012
Sponsor
The London Spine Centre
1. Study Identification
Unique Protocol Identification Number
NCT01741168
Brief Title
Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
Official Title
TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The London Spine Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracolumbar Burst Fractures Without Neurologic Deficit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TLSO
Arm Type
Active Comparator
Arm Description
TLSO brace 8-10 weeks
Arm Title
No Orthosis
Arm Type
Experimental
Arm Description
No Orthosis
Intervention Type
Other
Intervention Name(s)
TLSO
Other Intervention Name(s)
TLSO Aspen Medical Products, Irvine, CA, USA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Orthosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Description
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.
Time Frame
3 months post fracture
Secondary Outcome Measure Information:
Title
SF-36 physical component summary score
Time Frame
enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
Title
SF-36 mental component summary score
Time Frame
enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
VAS pain score
Time Frame
enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Title
Satisfaction with Treatment
Description
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.
Time Frame
enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
London Spine Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
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