Mohammed F Shamji1, Darren M Roffey, Darryl K Young, Rudy Reindl, Eugene K Wai. 1. *Division of Neurosurgery, University of Toronto, Toronto Western Hospital, Toronto †Clinical Epidemiology Program, Ottawa Hospital Research Institute ‡University of Ottawa Spine Program §Division of Orthopaedic Surgery, University of Ottawa, The Ottawa Hospital, Ottawa, ON ∥Division of Orthopaedic Surgery, McGill University Health Centre, Montreal General Hospital, Montreal, QC, Canada.
Abstract
STUDY DESIGN: Prospective, 2-center, observer-blinded, randomized controlled trial. OBJECTIVE: Investigate clinical and radiologic outcomes of bracing versus no-bracing in the treatment of stable thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: Management of thoracolumbar burst fractures depends upon clinical presentation of neurological deficit and radiographic features of fracture severity. Neurologically intact patients with mild deformity and biomechanical stability may be treated with conservative therapy. METHODS:Patients with stable (AO type A3), single level, thoracolumbar burst fractures between T12 and L2 with no neurological deficit were randomized to nonoperative treatment with a customized thoracolumbosacral orthosis (TLSO) or no-brace. Self-reported clinical outcomes of pain, disability, and health-related quality of life, and radiographic outcomes of kyphotic progression and loss of vertebral height, assessed by 2 independent reviewers blinded to treatment group, were measured at 6 months follow-up. RESULTS:Twenty-three consecutive eligible patients were included (TLSO: n=12; no-brace: n=11). There were no between-group differences regarding level of injury (P=0.75) and baseline spine geometry including fractional canal compromise (P=0.49), anterior loss of vertebral body height (P=0.28), and sagittal Cobb angle (P=0.13). In-hospital stay was significantly shorter in the no-brace group (mean: 2.8±3.0 d) compared with the TLSO group (mean: 6.3±2.1 d; P=0.004). At follow-up there were no differences in anterior loss of vertebral body height (TLSO: 12.5%±10.2% vs. no-brace: 11.9%±8.1%; P=0.88), kyphotic progression (TLSO: 5.3±4.4 degrees vs. no-brace 5.2±3.6 degrees; P=0.93), adverse events, or self-reported clinical outcomes. CONCLUSIONS:Neurologically intact patients with stable thoracolumbar burst fractures treated with or without bracing had similar radiographic and clinical outcomes at 6 months follow-up. The no-brace group had shorter in-hospital lengths of stay. Conservative therapy involving early mobilization without brace immobilization may be warranted. Further studies with a larger series of patients and longer follow-up are required for conclusive findings.
RCT Entities:
STUDY DESIGN: Prospective, 2-center, observer-blinded, randomized controlled trial. OBJECTIVE: Investigate clinical and radiologic outcomes of bracing versus no-bracing in the treatment of stable thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: Management of thoracolumbar burst fractures depends upon clinical presentation of neurological deficit and radiographic features of fracture severity. Neurologically intact patients with mild deformity and biomechanical stability may be treated with conservative therapy. METHODS:Patients with stable (AO type A3), single level, thoracolumbar burst fractures between T12 and L2 with no neurological deficit were randomized to nonoperative treatment with a customized thoracolumbosacral orthosis (TLSO) or no-brace. Self-reported clinical outcomes of pain, disability, and health-related quality of life, and radiographic outcomes of kyphotic progression and loss of vertebral height, assessed by 2 independent reviewers blinded to treatment group, were measured at 6 months follow-up. RESULTS: Twenty-three consecutive eligible patients were included (TLSO: n=12; no-brace: n=11). There were no between-group differences regarding level of injury (P=0.75) and baseline spine geometry including fractional canal compromise (P=0.49), anterior loss of vertebral body height (P=0.28), and sagittal Cobb angle (P=0.13). In-hospital stay was significantly shorter in the no-brace group (mean: 2.8±3.0 d) compared with the TLSO group (mean: 6.3±2.1 d; P=0.004). At follow-up there were no differences in anterior loss of vertebral body height (TLSO: 12.5%±10.2% vs. no-brace: 11.9%±8.1%; P=0.88), kyphotic progression (TLSO: 5.3±4.4 degrees vs. no-brace 5.2±3.6 degrees; P=0.93), adverse events, or self-reported clinical outcomes. CONCLUSIONS: Neurologically intact patients with stable thoracolumbar burst fractures treated with or without bracing had similar radiographic and clinical outcomes at 6 months follow-up. The no-brace group had shorter in-hospital lengths of stay. Conservative therapy involving early mobilization without brace immobilization may be warranted. Further studies with a larger series of patients and longer follow-up are required for conclusive findings.
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