SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures (SunBurst)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2036
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- participants needed
- 202
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- sponsor
- Karolinska Institutet
Summary
Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are considered standard of care. This study aims to compare outcome between surgical and non-surgical in patients with a single level TL burst fracture (AO A3/4) in a register-based randomized controlled trial (R-RCT).
Description
The study is a nationwide, multicenter, register-based randomized controlled trial. 202 patients with a single level TL burst fracture will be enrolled in the study by way of the Swedish Fracture Register. They will be randomized 1:1 to either surgery with posterior fixation or non-surgical treatment. The study is pragmatical in its approach, i.e., the treating physician can decide on details of the surgical treatment as well as details of the non-surgical treatment. In non-surgically treated patients brace treatment is not required, but a hyperextension brace may be offered. The subjects will be followed with patient reported outcomes, clinical assessments, and radiological assessments. Data will be collected from other national registers to compare sick leave, medical complications, pharmaceutical prescriptions and overall costs for each treatment.
Details
| Condition | Thoracolumbar Burst Fracture |
|---|---|
| Treatment | Surgical stabilization with posterior fixation |
| Clinical Study Identifier | NCT05003180 |
| Sponsor | Karolinska Institutet |
| Last Modified on | 23 October 2022 |
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