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Clinical Trials in Sweden / NCT05003180
Active, not recruiting Not applicable

StUdy oN Burst Fractures (SunBurst)

NCT05003180 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2021-09-01
Last updated
2026-02-18

Condition(s) studied

Thoracolumbar Burst Fracture

Investigational drug(s) / intervention(s)

Surgical stabilization

Surgical stabilization: The surgical stabilization can be either open or minimally invasive. The recommended procedure is posterior fixation with pedicle screws and rods. Both short and long segment fixation are allowed in the study. It is up to the treating surgeon to decide on fusion or decompression. If feasible, pedicle screws are inserted in the fractured vertebra.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
66 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Oslo University Hospital Oslo Oslo
Haukeland University Hospital Bergen Norway
Akershus University Hospital Oslo Norway
Stavanger University Hospital Stavanger Norway
St. Olavs Hospital Trondheim Norway
Sahlgrenska University Hospital Gothenburg Gothenburg
Linköping University Hospital Linköping Linköping
Skåne University Hospital Malmö Malmö
Stockholm South General Hospital Stockholm Stockholm County
University Hospital of Umeå Umeå Umeå
Uppsala University Hospital Uppsala Uppsala County
Halmstad Hospital Halmstad Sweden
Ryhov Hospital Jönköping Sweden
Kalmar Hospital Kalmar Sweden
Örebro University Hospital Örebro Sweden
Karolinska University Hospital Stockholm Sweden
Central Hospital of Västerås Västerås Sweden

More Uppsala University trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05003180 on ClinicalTrials.gov ↗ ← All trials in Sweden