Trials / Terminated
TerminatedNCT01751633
Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures
Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 38 (actual)
- Sponsor
- AO Clinical Investigation and Publishing Documentation · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Single Level Stable Thoracolumbar Fracture Type AO A3
- Multiple Level Stable Thoracolumbar Fracture Type AO A3
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical | |
| PROCEDURE | Conservative treatment |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-03-01
- Completion
- 2015-12-01
- First posted
- 2012-12-18
- Last updated
- 2020-08-13
Locations
8 sites across 6 countries: Brazil, Chile, Czechia, Germany, Italy, Portugal
Source: ClinicalTrials.gov record NCT01751633. Inclusion in this directory is not an endorsement.