Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial

Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
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.
Epistemonikos ID: 944e79f054bad7ed6d52036ad5a75fcff194b26e
First added on: Feb 19, 2024