Study protocol: The SunBurst trial-a register-based, randomized controlled trial on thoracolumbar burst fractures.

ABSTRACT

BACKGROUND AND PURPOSE: The treatment for patients with thoracolumbar burst fractures without neurological deficit or complete rupture of the posterior ligament complex (PLC) is controversial and includes both surgical and non-surgical options. Current evidence on which treatment is optimal remains inconclusive. In this study we compare surgical with non-surgical treatment. METHODS: The study is a nationwide, multicenter, register-based randomized controlled trial (R-RCT). Patients with a thoracolumbar burst fracture will be identified by the Swedish Fracture Register. The admitting physician will be notified during the registration process and the patient will be screened for eligibility. Patients, 18 to 66 years old without neurologic deficit to more than a single nerve root and without complete rupture of the PLC, are eligible for the study. 202 patients will be randomized in a 11 relation to either surgical or non-surgical treatment. Patient-reported outcome measures (PROMs), including the Oswestry Disability Index (ODI) and radiological data, will be collected at the time of injury, after 3-4 months, and after 1 year. Additional data from national health registries will be collected after 1 year. OUTCOME: The primary outcome is the ODI 1 year after injury. Secondary outcomes include additional PROMs, adverse events, drug consumption, sick leave, healthcare consumption, and imaging data. INTERPRETATION: The primary outcome is the ODI 1 year after injury. Secondary outcomes include additional PROMs, adverse events, drug consumption, sick leave, healthcare consumption, and imaging data. Estimated duration - The study started on September 1, 2021 and will continue for approximately 4 years. Trial registration - The trial is registered at www.clinicaltrials.com, NCT05003180.