Department of Orthopaedic Surgery, Radboud University Medical Center, Nijmegen, Netherlands
U.O. di Clinica Neurochirurgia Azienda Ospedaliero, Universitaria Policlinico, Catania, Italy
Bone Joint J. 2023 Mar 15;105-B(4):400-411. doi: 10.1302/0301-620X.105B4.BJJ-2022-0947.R2.
The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.
本研究旨在确定急性创伤性脊髓损伤（tSCI）患者早期手术治疗是否比晚期手术治疗在 12 个月后获得更好的神经恢复。从欧洲的 17 个中心招募了需要手术减压的 tSCI 患者。根据减压的时机，将患者分为早期（伤后≤12 小时）和晚期（伤后 12 小时至 14 天）组。在基线（伤后但在减压前）和 12 个月时进行美国脊髓损伤协会神经学（ASIA）检查。主要终点是从基线到 12 个月时下肢运动评分（LEMS）的变化。最终分析包括早期组 159 例和晚期组 135 例。早期组患者在手术治疗前神经功能损伤更为严重。对于未调整的完全病例分析，早期组的 LEMS 平均变化为 15.6（95%置信区间（CI）为 12.1 至 19.0），晚期组为 11.3（95%CI 为 8.3 至 14.3），两组之间的平均差异为 4.3（95%CI -0.3 至 8.8）。使用多重插补数据调整基线 LEMS、基线 ASIA 损伤量表（AIS）和倾向评分后，LEMS 变化的组间平均差异缩小至 2.2（95%CI -1.5 至 5.9）。与晚期手术减压相比，急性 tSCI 后早期手术减压在伤后 12 个月时并未导致统计学上显著或临床上有意义的神经改善。然而，这些结果并不影响急性非手术 tSCI 管理的既定需要。这是第一项表明基线失衡、天花板效应和随访失效率相结合可能导致未调整分析中高估早期手术减压效果的研究，这凸显了调整统计分析在急性 tSCI 研究中的重要性。
