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Administrative reason. Lack of funding.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | Surgical treatment according to one of the following:
|
| |
| Conservative treatment | Conservative treatment according to hospital's standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Back pain related disability (Roland-Morris Disability Questionnaire RMDQ) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up | |
| Pain (Numeric Rating Scale (NRS)) | Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU |
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Inclusion Criteria:
Age 18-65 years
Diagnosis of single or multiple stable thoracolumbar fracture(s)
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:
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140 subjects patients with thoracolumbar fractures will be assigned to ei-ther conservative or surgical treatment depending on the surgeon's decision. Patients will be treated at each institution per standard of care. Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Barbagallo, MD | Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy | Principal Investigator |
| Emiliano Vialle, MD | Catholic University of Parana - Curitiba, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitaria Cajuru | Curitiba | Brazil | ||||
| Hospital Cristo Redentor |
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| Conservative treatment | Procedure |
|
|
| 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 |
| Time to return to work | 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 |
| Porto Alegre |
| Brazil |
| Hospital Santa Marcelina | São Paulo | Brazil |
| Hospital Cristo Redentor | Santiago | Chile |
| Krajská nemocnice Liberec | Liberec | Czechia |
| Klinikum rechts der Isar der Technischen Universität München | Munich | Germany |
| Azienda Ospedaliero - Universitaria Policlinico | Catania | Italy |
| Hospital Garcia e Orta, EPE | Almada | Portugal |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000072700 | Conservative Treatment |
| D002133 | Calcium Sulfate |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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