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

• ClinicalTrials.gov Identifier: NCT01741168
• Recruitment Status: Completed
• First Posted: December 4, 2012
• Last Update Posted: December 4, 2012
• Sponsor: The London Spine Centre
• Information provided by (Responsible Party): The London Spine Centre

Tracking Information

• First Submitted Date: November 22, 2012
• First Posted Date: December 4, 2012
• Last Update Posted Date: December 4, 2012
• Study Start Date: June 2005
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Thoracolumbar Burst Fractures Without Neurologic Deficit

Intervention

• 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

• Active Comparator: TLSO
  TLSO brace 8-10 weeks
  Intervention: Other: TLSO
• Experimental: No Orthosis
  No Orthosis
  Intervention: Other: No Orthosis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2012): 97
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01741168
• Other Study ID Numbers: 11421
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: The London Spine Centre
• Original Responsible Party: Same as current
• Current Study Sponsor: The London Spine Centre
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: The London Spine Centre
• Verification Date: November 2012