Kuršumović Adisa, Rath Stefan A
Department of Neurosurgery, Spinal Surgery and Interventional Neuroradiology, Donauisar Klinikum Deggendorf, Deggendorf, Germany.
Med Devices (Auckl). 2018 Jun 7;11:193-200. doi: 10.2147/MDER.S167381. eCollection 2018.
Increased focus has been put on the use of "'real-world" data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of "real-world" patients by the screening criteria of an ongoing RCT.
This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation. Patients were stratified into two groups using the selection criteria of a pivotal RCT on the same device: Trial (met inclusion; n=44) or non-Trial (did not meet inclusion; n=120). Patient-reported outcomes, including Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg and back pain, and adverse events were collected from baseline to last follow-up (mean: Trial - 15.6 months; non-Trial - 14.6 months). Statistical analyses were performed with significance set at <0.05.
Patient-reported outcomes were not significantly different between groups at last (≥0.15) and clinical success (≥15-point improvement in ODI score; ≥20-point improvement in VAS scores) was achieved in both the groups. Three non-Trial (2.5%) and three Trial (6.8%) patients experienced symptomatic reherniation (=0.34). Rates of reoperation, ACD mesh dislocation/separation, and other radiographic findings were similar between groups (=1.00).
Outcomes with the ACD appeared advantageous in both the groups, particularly in comparison with historical reherniation rates reported in the same high-risk, large annular defect population. Stratification of this "real-world" series on the basis of RCT screening criteria did not result in significant between-group differences. These findings suggest that the efficacy of the ACD extends beyond the strictly defined patient population being studied in the RCT of this device. Furthermore, reducing the reherniation rate following lumbar discectomy has positive clinical and economic implications.
越来越多的注意力被放在利用“真实世界”数据来支持用于临床决策的随机临床试验（RCT）证据上。本研究的目的是在根据一项正在进行的RCT的筛查标准对一系列连续的“真实世界”患者进行分层后，评估一种环形闭合装置（ACD）的性能。
这是一项对164例因症状性腰椎间盘突出症接受有限椎间盘切除术联合ACD治疗的患者进行的单中心登记分析。使用关于同一装置的一项关键RCT的选择标准将患者分为两组：试验组（符合纳入标准；n = 44）或非试验组（不符合纳入标准；n = 120）。收集患者报告的结局，包括Oswestry功能障碍指数（ODI）以及腿部和背部疼痛的视觉模拟量表（VAS），并收集从基线到最后一次随访（平均：试验组 - 15.6个月；非试验组 - 14.6个月）的不良事件。进行统计学分析，显著性设定为<0.05。
两组患者报告的结局在最后（≥0.15）时无显著差异，并且两组均实现了临床成功（ODI评分改善≥15分；VAS评分改善≥20分）。3例非试验组（2.5%）和3例试验组（6.8%）患者出现症状性复发（P = 0.34）。两组之间再次手术率、ACD网片脱位/分离率以及其他影像学表现相似（P = 1.00）。
两组中使用ACD的结局似乎都具有优势，特别是与在相同高风险、大环形缺损人群中报告的既往复发率相比。根据RCT筛查标准对这个“真实世界”系列进行分层并未导致组间出现显著差异。这些发现表明，ACD的疗效超出了该装置RCT中所研究的严格定义的患者群体。此外，降低腰椎间盘切除术后的复发率具有积极的临床和经济意义。
