Lauryssen Carl, Jackson Robert J, Baron Jeffrey M, Tallarico Richard A, Lavelle William F, Deutsch Harel, Block Jon E, Geisler Fred H
a Neurosurgical Spine Institute , Lakeway , TX 78738 , USA.
b Orange County Neurosurgical Associates , Laguna Hills , CA 92653 , USA.
Expert Rev Med Devices. 2015;12(6):763-9. doi: 10.1586/17434440.2015.1100071. Epub 2015 Oct 21.
To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis.
Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months.
Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs. 52%), leg pain (70% vs. 62%), ODI (51% vs. 47%) and ZCQ symptom severity (37% vs. 29%) and physical function (36% vs. 32%).
Both treatments provide effective and durable symptom relief of claudicant symptoms. This stand-alone interspinous spacer offers the patient a minimally invasive option with less surgical risk.
将一项经美国食品药品监督管理局(FDA)批准的椎间融合器的前瞻性随机对照试验的两年临床结果,与19项关于减压性椎板切除术治疗腰椎管狭窄症的已发表研究结果汇总进行比较。
比较术前以及术后12个月和24个月时,接受椎间融合器治疗和椎板切除术治疗的患者的背痛、腿痛、奥斯威斯利功能障碍指数(ODI)以及苏黎世跛行问卷(ZCQ)值。
从基线到24个月,各项指标的改善百分比均表明,接受椎间融合器治疗的患者在背痛(65%对52%)、腿痛(70%对62%)、ODI(51%对47%)以及ZCQ症状严重程度(37%对29%)和身体功能(36%对32%)方面更具优势。
两种治疗方法均能有效且持久地缓解跛行症状。这种独立的椎间融合器为患者提供了一种手术风险较小的微创选择。