StUdy oN Burst Fractures (SunBurst)

Launched by UPPSALA UNIVERSITY · Aug 4, 2021

Keywords

ClinConnect Summary

The SunBurst trial is studying how to best treat a specific type of spinal injury called a thoracolumbar burst fracture, which often happens due to accidents or trauma. The goal of this study is to compare two treatment methods: surgery versus non-surgical options, to see which one leads to better outcomes for patients with a single level burst fracture. The trial is open to adults aged 18 to 66 who have recently been diagnosed with this type of fracture and can provide informed consent to participate.

If you or someone you know is considering joining this trial, participants can expect to be randomly assigned to either the surgical or non-surgical treatment group. This means that neither the patient nor the doctor will choose the treatment method. The study is currently recruiting participants, and those with certain conditions, like more severe spinal injuries or other serious health issues, may not be eligible. This trial aims to help doctors better understand the best ways to treat thoracolumbar burst fractures, ultimately improving care for future patients.

Gender

ALL

Eligibility criteria

• 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