About this trial
Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms.
The study's precise objectives are to:
1. evaluate the clinical outcome (Oswestry Disability Index) 2. evaluate the radiography result (restoration and maintenance of spinal alignment) 3. determine the prevalence of complications
at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.
Eligibility criteria
Qualifiers
Age 18 - 70 years at inclusion
Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body)
Informed consent for study participation
Disqualifiers
Injury of the posterior tension band/posterior column of the thoracolumbar spine
Any neurological deficit (American Spinal Injury Association Impairment Scale [AISA] Grade A-D)
Pathological vertebral body fractures (diagnosed by MRI and CT scan), which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
Concomitant spinal fractures at any other level of the spine outside the T10-L3 level, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
Trial design
Treatments tested in this trial
- Surgical stabilization
Treatment groups
Sponsors and collaborators
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Cantonal Hospital of St. Gallen
Collaborator