Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
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ClinicalTrials.gov Identifier: NCT01741168 |
Recruitment Status :
Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
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Sponsor:
The London Spine Centre
Information provided by (Responsible Party):
The London Spine Centre
Tracking Information | |||
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First Submitted Date ICMJE | November 22, 2012 | ||
First Posted Date ICMJE | December 4, 2012 | ||
Last Update Posted Date | December 4, 2012 | ||
Study Start Date ICMJE | June 2005 | ||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Roland Morris Disability Questionnaire [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury | ||
Official Title ICMJE | TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial | ||
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. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Thoracolumbar Burst Fractures Without Neurologic Deficit | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
97 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | September 2011 | ||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 60 Years (Child, Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01741168 | ||
Other Study ID Numbers ICMJE | 11421 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | The London Spine Centre | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | The London Spine Centre | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | The London Spine Centre | ||
Verification Date | November 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |