Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
NCT01741168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2012-12-04
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.
Conditions
- Thoracolumbar Burst Fractures Without Neurologic Deficit
Interventions
- OTHER
-
TLSO
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.
- OTHER
-
No 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 & Collaborators
-
The London Spine Centre
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Primary Completion
- 2010-09-30
- Completion
- 2011-09-30
Countries
- Canada
Study Locations
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