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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

Tracking Information
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
 (submitted: November 30, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • SF-36 physical component summary score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years ]
  • SF-36 mental component summary score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  • VAS pain score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ]
  • 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.
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
Condition  ICMJE Thoracolumbar Burst Fractures Without Neurologic Deficit
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: TLSO
    TLSO brace 8-10 weeks
    Intervention: Other: TLSO
  • Experimental: No Orthosis
    No Orthosis
    Intervention: Other: No Orthosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Responsible Party The London Spine Centre
Study Sponsor  ICMJE The London Spine Centre
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