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Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741168
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
The London Spine Centre

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.

Condition or disease Intervention/treatment Phase
Thoracolumbar Burst Fractures Without Neurologic Deficit Other: TLSO Other: No Orthosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
Study Start Date : June 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: TLSO
TLSO brace 8-10 weeks
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 Name: TLSO Aspen Medical Products, Irvine, CA, USA

Experimental: No Orthosis
No Orthosis
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. SF-36 physical component summary score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years ]
  2. SF-36 mental component summary score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  3. VAS pain score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ]
  4. Satisfaction with Treatment [ Time Frame: 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.



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741168


Locations
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Canada, Ontario
London Spine Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
The London Spine Centre
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Responsible Party: The London Spine Centre
ClinicalTrials.gov Identifier: NCT01741168    
Other Study ID Numbers: 11421
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Neurologic Manifestations
Fractures, Bone
Wounds and Injuries
Nervous System Diseases