Multiple Level Stable Thoracolumbar Fracture Type AO A3 Clinical Trial
— FA3Official title:
Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
| NCT number | NCT01751633 |
| Other study ID # | Spine FA3 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | December 2015 |
| Verified date | August 2020 |
| Source | AO Innovation Translation Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 38 |
| Est. completion date | December 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital Universitaria Cajuru | Curitiba | |
| Brazil | Hospital Cristo Redentor | Porto Alegre | |
| Brazil | Hospital Santa Marcelina | São Paulo | |
| Chile | Hospital Cristo Redentor | Santiago de Chile | |
| Czechia | Krajská nemocnice Liberec | Liberec | |
| Germany | Klinikum rechts der Isar der Technischen Universität München | Munich | |
| Italy | Azienda Ospedaliero - Universitaria Policlinico | Catania | |
| Portugal | Hospital Garcia e Orta, EPE | Almada |
| Lead Sponsor | Collaborator |
|---|---|
| AO Clinical Investigation and Publishing Documentation |
Brazil, Chile, Czechia, Germany, Italy, Portugal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Roland-Morris Disability Questionnaire (RMDQ) | Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ) | 6 week follow up | |
| Secondary | Back pain related disability (Roland-Morris Disability Questionnaire RMDQ) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up | ||
| Secondary | Pain (Numeric Rating Scale (NRS)) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU | ||
| Secondary | Radiologic progress taking into account RX, CT and optionally MRI | baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months | ||
| Secondary | Quality of return to work (Denis Work Scale) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up | ||
| Secondary | Time to return to work | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up | ||
| Secondary | Conservative treatment failure rate (eg, change to surgical treatment) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up | ||
| Secondary | Rates of local adverse events (AE) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up |