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

NCT ID: NCT01741168

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Thoracolumbar Burst Fractures Without Neurologic Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TLSO

TLSO brace 8-10 weeks

Group Type ACTIVE_COMPARATOR

TLSO

Intervention Type 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.

No Orthosis

No Orthosis

Group Type EXPERIMENTAL

No Orthosis

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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TLSO Aspen Medical Products, Irvine, CA, USA

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The London Spine Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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London Spine Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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11421

Identifier Type: -

Identifier Source: org_study_id