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

The London Spine Centre

Status: Completed

Conditions: Thoracolumbar Burst Fractures Without Neurologic Deficit

Treatments: Other: TLSO; Other: No Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01741168

11421

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

TLSO

Active Comparator group

Description:

TLSO brace 8-10 weeks

Treatment:

Other: TLSO

No Orthosis

Experimental group

Description:

No Orthosis

Treatment:

Other: No Orthosis