CompletedNot Applicable

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

Canada97 participantsStarted 2005-06

Plain-language 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.

Who can participate

Age range

16 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Roland Morris Disability Questionnaire

Timeframe: 3 months post fracture

Trial details

NCT IDNCT01741168

SponsorThe London Spine Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Thoracolumbar Burst Fractures Without Neurologic Deficit trials