Haghnegahdar A, Behjat R, Saadat S, Badhiwala J, Farrokhi MR, Niakan A, Eghbal K, Barzideh E, Shahlaee A, Ghaffarpasand F, Ghodsi Z, Vaccaro AR, Sadeghi-Naini M, Fehlings MG, Guest JD, Derakhshan P, and Rahimi-Movaghar V
Convincing clinical evidence exists to support early surgical decompression in the setting of cervical spinal cord injury (SCI). However, clinical evidence on the effect of early surgery in patients with thoracic and thoracolumbar (from T1 to L1 [T1-L1]) SCI is lacking and a critical knowledge gap remains. This randomized controlled trial (RCT) sought to evaluate the safety and efficacy of early (<24 h) compared with late (24-72 h) decompressive surgery after T1-L1 SCI. From 2010 to 2018, patients (≥16 years of age) with acute T1-L1 SCI presenting to a single trauma center were randomized to receive either early (<24 h) or late (24-72 h) surgical decompression. The primary outcome was an ordinal change in American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade at 12-month follow-up. Secondary outcomes included complications and change in ASIA motor score (AMS) at 12 months. Outcome assessors were blinded to treatment assignment. Of 73 individuals whose treatment followed the study protocol, 37 received early surgery and 36 underwent late surgery. The mean age was 29.74 ± 11.4 years. In the early group 45.9% of patients and in the late group 33.3% of patients had a ≥1-grade improvement in AIS (odds ratio [OR] 1.70, 95% confidence interval [CI]: 0.66-4.39, p = 0.271); significantly more patients in the early (24.3%) than late (5.6%) surgery group had a ≥2-grade improvement in AIS (OR 5.46, 95% CI: 1.09-27.38, p = 0.025). There was no statistically significant difference in the secondary outcome measures. Surgical decompression within 24 h of acute traumatic T1-L1 SCI is safe and is associated with improved neurological outcome, defined as at least a 2-grade improvement in AIS at 12 months., Competing Interests: No competing financial interests exist except for Alex R Vaccaro as follows: Replication Medical, Inc., Stock/Stock Option Ownership Interest; Medtronic, Consulting/Independent Contractor, Receipt of Royalty Payments; Stryker Spine, Consulting/Independent Contractor, Receipt of Royalty Payments; Globus, Consulting/Independent Contractor, Receipt of Royalty Payments; Paradigm Spine, Stock/Stock Option Ownership Interests; Stout Medical, Consulting/Independent Contractor, Stock/Stock Option Ownership Interests; Progressive Spinal Technologies, Service on Scientific Advisory Board/Board of Directors/Service on Committees, Stock/Stock Option Ownership Interest; Advanced Spinal Intellectual Properties, Stock/Stock Option Ownership Interests; Aesculap, Receipt of Royalty Payments; Spine Medica, Stock/Stock Option Ownership Interests; Computational Biodynamics, Stock/Stock Option Ownership Interest; Spinology, Stock/Stock Option Ownership Interests; Flagship Surgical, Service on Scientific Advisory Board/Board of Directors/Service on Committees, Stock/Stock Option Ownership Interests; Cytonics, Stock/Stock Option Ownership Interests; Bonovo Orthopaedics, Stock/Stock Option Ownership Interests; Electrocore, Stock/Stock Option Ownership Interests; Insight Therapeutics, Stock/Stock Option Ownership Interests; Flow Pharma, Stock/Stock Option Ownership Interests; Rothman Institute and Related Properties, Stock/Stock Option Ownership Interests; AO Spine, Service on Scientific Advisory Board/Board of Directors/Service on Committees; Innovative Surgical Design, Consulting/Independent Contractor, Service on Scientific Advisory Board/Board of Directors/Service on Committees, Stock/Stock Option Ownership Interests; Orthobullets, Consulting/Independent Contractor; Thieme, Receipt of Royalty Payments, Deputy Editor/Editor/Editorial Board; Jaypee, Receipt of Royalty Payments; Elsevier, Receipt of Royalty Payments; Taylor Francis/Hodder and Stoughton, Receipt of Royalty Payments; Expert testimony, Consulting/Independent Contractor; Vertiflex, Stock/Stock Option Ownership Interests; Avaz Surgical, Stock/Stock Option Ownership Interests; Clinical Spine Surgery, Deputy Editor/Editor/Editorial Board; Spine Journal, Deputy Editor/Editor/Editorial Board; Prime Surgeons, Service on Scientific Advisory Board/Board of Directors/Service on Committees, Stock/Stock Option Ownership Interests; Dimension Orthotics, LLC, Stock/Stock Option Ownership Interests; Spine Therapy Network, Inc., Service on Scientific Advisory Board/Board of Directors/Service on Committees; SpineWave, Consulting/Independent Contractor, Receipt of Royalty Payments; Atlas Spine, Consulting/Independent Contractor, Receipt of Royalty Payments; Nuvasive, Consulting/Independent Contractor, Stock/Stock Option Ownership Interests; Parvizi Surgical Innovation, Service on Scientific Advisory Board/Board of Directors/Service on Committees, Stock/Stock Option Ownership Interests; Franklin Bioscience, Stock/Stock Option Ownership Interests; Sentryx, Service on Scientific Advisory Board/Board of Directors/Service on Committees., (© Ali Haghnegahdar et al., 2020; Published by Mary Ann Liebert, Inc.)