Effectiveness of Conservative Treatment in Patients with AOSpine Type A2 and A3 Fractures of the Thoracic and Lumbar Spine Without Neurological Deficit: A Protocol for a Prospective Cohort Study

Abstract

Abstract Introduction: One of the important yet unresolved questions is the choice between conservative and surgical treatment for compressive and burst fractures. Published prospective studies to date have provided contradictory evidence. Hitchon et al. demonstrate the relative superiority of conservative treatment in the long term, Siebenga et al. favor surgery, and Shen et al. suggest no difference. Currently, according to the clinicaltrials.gov database, only two active multicenter cohort studies are dedicated to this issue, and three more were terminated in the years following the start of the COVID-19 pandemic. This fact indicates the high relevance and active interest of the surgical community in this issue. Methods and analysis. This study is a prospective cohort study. All enrolled subjects will be divided into two concurrent groups based on the treatment technique applied. The main group (prospective) will consist of patients who underwent conservative therapy. The control group (historical control) will be comprised of patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine. In total, 80 patients (40 per group) are planned to be enrolled in the study. The primary endpoint is the Oswestry Disability Index dynamics at the end of the 12-month follow-up. Secondary outcomes will be assessed using the SF-36 scale and EQ-5D-5L. Additional parameters will include sagittal balance of the spine, fusion results, total cost of treatment, and hospital stay over one year. Follow-up examinations will be performed at 3, 6, and 12 months. Ethics and dissemination. The current study will be conducted in accordance with the Helsinki Declaration of the World Medical Association. The provided protocol was approved by the local ethics committees of the Sklifosovsky Research Institute for Emergency Medicine (Approval No. 5–23 20.09.2023) and the Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine (Approval No. 7/1 16.10.2023). The preliminary and final results of the study will be presented in peer-reviewed neurosurgery and spinal journals and at relevant international conferences. Trial registration number NCT06059820