TerminatedNot Applicable

Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures

Stopped: Administrative reason. Lack of funding.

Brazil, Chile, Czechia38 participantsStarted 2013-01

Plain-language summary

Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.

Who can participate

Age range

18 Years – 65 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: * Age 18-65 years * Diagnosis of single or multiple stable thoracolumbar fracture(s) * Level T10- L3 * Type AO A3 or A4 * Radiologically confirmed by Rx or CT * Fracture induced kyphotic deformity lower or equal to 20-35 degrees * Definitive treatment (surgical or conservative) within 10 days after injury * American Spinal Injury Association (ASIA) Impairment Scale = E (normal ) * Ability to understand patient information / informed consent form * Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs) * Signed informed consent Exclusion Criteria: * Open fracture * Polytrauma * Pathologic fracture * Disruption of the posterior ligamentous complex between T10 and L3 * Clinically evident osteoporosis as assessed by the investigator * Spinal luxation * Associated severe lesions as assessed by the investigator * Spinal lesion due to gun or projectile * Pre-existing spinal column deformity * Prior spinal surgeries * BMI \> 40 kg/m2 * Any severe medically not managed systemic disease * Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment * Pregnancy or women planning to conceive within the study period * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

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 (RMDQ)

Timeframe: 6 week follow up

Trial details

NCT IDNCT01751633

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Single Level Stable Thoracolumbar Fracture Type AO A3 trials