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

TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial

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.

Study Overview

• Status: Completed
• Conditions: Thoracolumbar Burst Fractures Without Neurologic Deficit
• Intervention / Treatment: Other: TLSO; Other: No Orthosis

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
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Spine Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: TLSO Aspen Medical Products, Irvine, CA, USA
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Questionnaire	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.	3 months post fracture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 physical component summary score		enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
SF-36 mental component summary score		enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
VAS pain score		enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Satisfaction with Treatment	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.	enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: The London Spine Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations
• Other Study ID Numbers: 11421