Nunley Pierce D, Patel Vikas V, Orndorff Douglas G, Lavelle William F, Block Jon E, Geisler Fred H
Spine Institute of Louisiana, Shreveport, Louisiana, USA.
The Spine Center, University of Colorado Hospital, Denver, Colorado, USA.
World Neurosurg. 2017 Aug;104:279-283. doi: 10.1016/j.wneu.2017.04.163. Epub 2017 May 4.
To determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous process decompression using the Superion device.
The 4-year Superion data were extracted from a randomized, controlled Food and Drug Administration investigational device exemption trial. Patients with intermittent neurogenic claudication relieved with back flexion who failed at least 6 months of nonsurgical management were enrolled. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf) and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI). At 4-year follow-up, 89 of the 122 patients (73%) provided complete clinical outcome evaluations.
At 4 years after index procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success on at least 2 of 3 ZCQ domains. Individual component responder rates were 83% (74/89), 79% (70/89), and 87% (77/89) for ZCQss, ZCQpf, and ZCQps; 78% (67/86) and 66% (57/86) for leg and back pain VAS; and 62% (55/89) for ODI. Patients with Superion also demonstrated percentage improvements over baseline of 41%, 40%, 73%, 69%, and 61% for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI. Within-group effect sizes all were classified as very large (>1.0): 1.49, 1.65, 1.42, 1.12, and 1.46 for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI.
Minimally invasive implantation of the Superion device provides long-term, durable relief of symptoms of intermittent neurogenic claudication for patients with moderate lumbar spinal stenosis.
使用Superion装置对中度腰椎管狭窄症患者进行微创独立棘突间减压，以确定其4年的临床疗效。
4年的Superion数据来自一项随机对照的美国食品药品监督管理局研究器械豁免试验。纳入经至少6个月非手术治疗失败、后伸位可缓解间歇性神经源性跛行的患者。疗效指标包括苏黎世跛行问卷（ZCQ）症状严重程度（ss）、身体功能（pf）和患者满意度（ps）子域、腿部和背部疼痛视觉模拟量表（VAS）以及Oswestry功能障碍指数（ODI）。在4年随访时，122例患者中的89例（73%）提供了完整的临床疗效评估。
在初次手术后4年，89例接受Superion治疗的患者中有75例（84.3%）在ZCQ的3个域中的至少2个域显示临床成功。ZCQss、ZCQpf和ZCQps的个体成分缓解率分别为83%（74/89）、79%（70/89）和87%（77/89）；腿部和背部疼痛VAS分别为78%（67/86）和66%（57/86）；ODI为62%（55/89）。接受Superion治疗的患者在ZCQss、ZCQpf、腿部疼痛VAS、背部疼痛VAS和ODI方面相对于基线的改善百分比分别为41%、40%、73%、69%和61%。组内效应量均被分类为非常大（>1.0）：ZCQss、ZCQpf、腿部疼痛VAS、背部疼痛VAS和ODI分别为1.49、1.65、1.42、1.12和1.46。
微创植入Superion装置可为中度腰椎管狭窄症患者提供长期、持久的间歇性神经源性跛行症状缓解。
