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

NCT01741168 | Completed

• 1 other identifier: 11421
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracolumbar Burst Fractures Without Neurologic Deficit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

Study Arms (2)

TLSO

ACTIVE COMPARATOR

TLSO brace 8-10 weeks

Other: TLSO

No Orthosis

EXPERIMENTAL

No Orthosis

Other: No Orthosis

Interventions

TLSO OTHER

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.

Also known as: TLSO Aspen Medical Products, Irvine, CA, USA

TLSO

No Orthosis OTHER

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.

No Orthosis

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The London Spine Centre: lead

Study Sites (1)

London Spine Centre

London, Ontario, N6A 5W9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 4, 2012
• Study Start: June 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

CA (1)