Study Protocol for a Randomized Controlled Clinical Trial on the Outcome of Surgical Versus Primary Nonsurgical Treatment of Traumatic Thoracolumbar Spine Burst Fractures in Patients Without Neurological Symptoms-A34RCT.

Abstract

Background and objectives: There are still major global differences in the treatment of acute traumatic thoracolumbar burst fractures in patients without neurological deficits and without posterior column injury. Treatment strategies range from conservative treatment with orthosis or early functional mobilization to various surgical stabilization techniques. The study's objectives are to evaluate the clinical (Oswestry Disability Index [ODI]) and radiographical outcomes (restoration and maintenance of spinal alignment; injury of the affected intervertebral disk) and determine the prevalence of complications until 24 months of follow-up.

Methods: The study is designed as a randomized, controlled, noninferiority clinical trial. All patients with a thoracolumbar burst fracture (Arbeitsgemeinschaft für Osteosynthesefragen spine type A3 or A4) age 18 to 70 years without neurological deficit and without posterior ligament injury can be enrolled. We will randomly assign 52 patients for either surgical or nonsurgical treatment. The surgical group will receive combined anterior-posterior (360°) spinal stabilization therapy. Participants in the nonsurgical group will be treated with a 3-point hyperextension orthosis for 6 weeks. The primary outcome is the difference in ODI at 2 years after injury.

Expected outcomes: We expect to find that conservative treatment of burst fractures in the thoracolumbar spine will be noninferior to the surgical treatment.

Discussion: This study will provide high-quality data comparing a modern surgical treatment regime with a standardized conservative treatment in patients with thoracolumbar burst fractures.