SunBurst (StUdy oN Burst Fractures) - a National, Multicenter, Register-based, Randomized Controlled Trial on Thoracolumbar Burst Fractures (SunBurst)

  • End date
    Dec 31, 2036
  • participants needed
  • sponsor
    Karolinska Institutet
Updated on 23 October 2022


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).


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.

Condition Thoracolumbar Burst Fracture
Treatment Surgical stabilization with posterior fixation
Clinical Study IdentifierNCT05003180
SponsorKarolinska Institutet
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

A single level thoracolumbar (Th10-L3) burst fracture, A3 or A4, according to the AO Spine classification
Aged 18-66 years
Informed consent
Acute injury with diagnosis and treatment within 2 weeks
May have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment
May have a single nerve root injury

Exclusion Criteria

Unable to consent, no consent given or not informed
Neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury
Definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on MRI
Patients with ankylosing spinal disorders spanning the fracture area
Prior spinal surgeries within the fractured area
Open vertebral fracture
Additional injury which would impair early ambulation, e.g., long bone fractures, severe head injury, long-lasting intensive care
Patients not deemed suitable due to severe co-morbidities. (E.g., established osteoporosis that would impair the possibility to maintain integrity of spinal implants, pathological fractures, severe cardiac or pulmonary compromise, or other systemic disease that would result in such high anesthesiologic risk that surgery would not be attempted.)
Patients already included in the study cannot be randomized again if they get an additional spine fracture
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