Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.
Eur Spine J. 2018 Dec;27(12):3016-3024. doi: 10.1007/s00586-017-5356-4. Epub 2017 Oct 25.
If surgery for thoracolumbar incomplete cranial burst fractures (Magerl A3.1.1) is necessary, the ideal stabilization strategy still remains undetermined. To justify posterior-anterior stabilization, which generates higher costs and potentially higher morbidity vs. posterior-only stabilization, clinical trials with sufficient power and adequate methodology are required. This prospective randomized single-centre pilot trial was designed to enable sufficient sample-size calculation for a randomized multicentre clinical trial (RASPUTHINE).
Patients with a traumatic thoracolumbar (Th11-L2) incomplete burst fracture (Magerl A3.1.1) were randomly assigned either to the interventional group (posterior-anterior) or to the control group (posterior-only). Primary endpoint of the study was the clinical outcome measured using the Oswestry Disability Index (ODI) at 24 months. Radiological outcome was assessed as secondary endpoint by evaluation of mono- and bisegmental kyphotic angulation and monosegmental fusion.
21 patients were randomly assigned to interventional group (n = 9) or control group (n = 12). One posterior-only treated patient showed a severe initial loss of correction resulting in a crossover to additional anterior bisegmental fusion. The ODI measures at the primary study endpoint showed less but insignificant (p = 0.67) disability for the interventional group over the control group (13.3 vs. 19.3%). Comparison of preoperative bisegmental kyphosis in supine position with the bisegmental kyphosis at 24-month FU in upright position showed a worsened kyphosis for the control group (10.7° → 15.6°), whereas an improved kyphosis (11° → 8.3°) was detectable for the interventional group.
The results of this pilot RCT showed less disability for the posterior-anterior group linked with a significant better restoration of the sagittal profile in comparison with the posterior-only group. To detect a clinically significant difference using the ODI and assuming a 20% loss of FU rate, a total of 266 patients have to be studied in the multicentre trial.
对于胸腰椎不稳定性爆裂性骨折（Magerl A3.1.1）是否需要手术治疗，理想的固定策略仍不确定。为了证明前后联合固定（与单纯后路固定相比，费用更高，潜在并发症更多）的合理性，需要进行具有足够效力和适当方法学的临床试验。本前瞻性随机单中心试验旨在为多中心临床试验（RASPUTHINE）提供足够的样本量计算。
将创伤性胸腰椎（Th11-L2）不稳定性爆裂性骨折（Magerl A3.1.1）患者随机分为干预组（前后联合）或对照组（单纯后路）。研究的主要终点是 24 个月时使用 Oswestry 功能障碍指数（ODI）评估的临床结果。通过评估单节段和双节段后凸角度和单节段融合，将影像学结果作为次要终点进行评估。
21 例患者被随机分配至干预组（n=9）或对照组（n=12）。1 例单纯后路治疗的患者出现严重的初始矫正丢失，导致额外的前路双节段融合。主要研究终点的 ODI 测量值显示，干预组的残疾程度低于对照组，但无统计学意义（p=0.67）（13.3 对 19.3%）。与 24 个月随访时的直立位相比，术前仰卧位的双节段后凸角度与 24 个月随访时的双节段后凸角度相比，对照组的后凸角度恶化（10.7°→15.6°），而干预组的后凸角度改善（11°→8.3°）。
本试验的结果表明，与单纯后路组相比，前后联合组的残疾程度较低，矢状面轮廓的恢复明显更好。假设随访丢失率为 20%，使用 ODI 检测有临床意义的差异，需要在多中心试验中研究总共 266 例患者。
