Krappel Ferdinand, Brayda-Bruno Marco, Alessi Giovanni, Remacle Jean-Michel, Lopez Luis Alberto, Fernández Jesus Javier, Maestretti Gianluca, Pfirrmann Christian W A
Spitalzentrum Oberwallis, Ueberlandstr. 14, CH 3900, Brig, Switzerland.
I.R.C.C.S. Istituto Ortopedico Galeazzi, Milan, Italy.
Eur Spine J. 2017 Mar;26(3):865-876. doi: 10.1007/s00586-016-4796-6. Epub 2016 Oct 4.
To investigate the short and medium term efficacy and patient outcomes of DIAM spinal stabilization system on back pain, disability, leg pain and quality of life.
165 patients were enrolled; 146 patients with a single level disc herniation (L2 to L5) were randomized: 75 investigational (herniectomy and DIAM) and 71 control (herniectomy alone) treated and followed up for 24 months.
Significant improvements overtime (P < 0.001) in both groups but not significantly different between groups for visual analog scale (VAS) back pain at 6 months (investigational -3.97 ± 2.55 vs control-3.37 ± 3.15, P = 0.228) and Oswestry Disability Index (ODI) at 12 months (-38.55 ± 20.10 vs -37.19 ± 22.61, P = 0.719). For both outcomes, there was no statistically significant difference between the groups, at all postoperative time points. Although the enrolment ended before the intended sample size (308 patients) was reached, the number of patients reaching the VAS back pain minimally clinically important difference (MCID) of ≥2.2 at 6 months was higher in the investigational (79.4 % vs control 57.1 %, P = 0.008). These results were sustained throughout 24 months (82.8 vs 64.4 %, P < 0.05). In average, surgical duration (P < 0.001), blood loss (P = 0.029) and skin incision (P < 0.001) in the investigational were 10 min longer, 22.5 ml greater and 2.0 cm wider than control group (median values). Improved tertiary outcomes from BL to 24 mo in both groups (investigational vs control): VAS leg pain (mean decrease -6.41 ± 2.57 to -6.41 vs -5.61 ± to -3.30); improved quality of life (SF-36: 20.68 ± 9.44 vs 16.90 ± 10.74); pain medication reduction: 56.7 vs 47.9 %; return to work: 45.7 vs 38.0 %. Adverse event rates: 68.5 % investigational and 66.2 % control.
This is the first randomized controlled trial to report equivalent efficacy and safety of herniectomy with or without DIAM spinal stabilizing device. Leg pain, back pain and the level of disability were not significantly different between groups; however, number of patients reaching the MCID for back pain was significantly higher in the investigational group at 6 through 24 months.
探讨DIAM脊柱稳定系统对背痛、功能障碍、腿痛及生活质量的短期和中期疗效及患者预后。
纳入165例患者；146例单节段椎间盘突出症（L2至L5）患者被随机分组：75例接受研究治疗（椎间盘切除术联合DIAM），71例接受对照治疗（单纯椎间盘切除术），并随访24个月。
两组患者随时间均有显著改善（P < 0.001），但在6个月时，两组间视觉模拟量表（VAS）背痛评分（研究组-3.97 ± 2.55，对照组-3.37 ± 3.15，P = 0.228）及12个月时Oswestry功能障碍指数（ODI）评分（-38.55 ± 20.10 vs -37.19 ± 22.61，P = 0.719）差异均无统计学意义。在所有术后时间点上，两组在这两个结局指标上均无统计学显著差异。尽管在达到预定样本量（308例患者）之前研究就已结束，但在6个月时达到VAS背痛最小临床重要差异（MCID）≥2.2的患者数量，研究组高于对照组（79.4% vs 57.1%，P = 0.008）。这些结果在整个24个月期间持续存在（82.8% vs 64.4%，P < 0.05）。平均而言，研究组手术时间（P < 0.001）、失血量（P = 0.029）及皮肤切口长度（P < 0.001）分别比对照组中位数长10分钟、多22.5毫升及宽2.0厘米。两组从基线至24个月的三级结局均有改善（研究组vs对照组）：VAS腿痛评分（平均下降-6.41 ± 2.57至-6.41 vs -5.61 ±至-3.30）；生活质量改善（SF-36：20.68 ± 9.44 vs 16.90 ± 10.74）；止痛药物使用减少：56.7% vs 47.9%；恢复工作：45.7% vs 38.0%。不良事件发生率：研究组为68.5%，对照组为66.2%。
这是第一项随机对照试验，报告了椎间盘切除术联合或不联合DIAM脊柱稳定装置的等效疗效和安全性。两组间腿痛、背痛及功能障碍水平差异无统计学意义；然而，在6至24个月期间研究组达到背痛MCID的患者数量显著高于对照组。
