Single Level Stable Thoracolumbar Fracture Type AO A3, Multiple Level Stable Thoracolumbar Fracture Type AO A3
Conditions
Keywords
Burst fractures, Thoracic or Lumbar Vertebrae/injuries [MeSH], Thoracic or Lumbar Vertebrae/surgery [MeSH], Spinal Fusion/methods [MeSH], Thoracolumbar fracture management, Quality of life, Functional outcome
Brief 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.
Interventions
PROCEDURESurgical
PROCEDUREConservative treatment
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire (RMDQ) | 6 week follow up | Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ) |
Secondary
| Measure | Time frame |
|---|---|
| Pain (Numeric Rating Scale (NRS)) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU |
| Radiologic progress taking into account RX, CT and optionally MRI | baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months |
| Quality of return to work (Denis Work Scale) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up |
| Back pain related disability (Roland-Morris Disability Questionnaire RMDQ) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up |
| Conservative treatment failure rate (eg, change to surgical treatment) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up |
| Rates of local adverse events (AE) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up |
| Time to return to work | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up |
Countries
Brazil, Chile, Czechia, Germany, Italy, Portugal
Outcome results
None listed