StUdy oN Burst Fractures (SunBurst) (NCT05003180) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
StUdy oN Burst Fractures (SunBurst)
Norway202 participantsStarted 2021-09-01
Plain-language 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 randomized controlled trial (RCT).
Who can participate
Age range18 Years – 66 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Group difference in Oswestry Disability Index (ODI) 1 year after the fracture.