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The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment

机译：美国食品药品监督管理局批准更换腰椎间盘突出症后的头18个月：在研究性器械豁免研究环境之外的不良事件报道

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BackgroundIntroduction of a new surgical technology may result in higher rates of adverse events compared with rates reported in the study performed to gain regulatory approval. The purpose of our study was to describe the incidence of reported adverse events during the first 18 months following US Food and Drug Administration (FDA) approval of the first lumbar arthroplasty device available in the United States and to discern data trends.

机译：背景技术与获得监管机构批准的研究中报道的发生率相比，引入新的外科技术可能导致更高的不良事件发生率。我们研究的目的是描述在美国食品药品监督管理局（FDA）批准美国首个腰椎关节置换术装置后的头18个月内报告的不良事件发生率，并观察数据趋势。

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期刊名称 International Journal of Spine Surgery
作者
Scott L. Blumenthal; Richard D. Guyer; Fred H. Geisler; Paul C. McAfee; John J. Regan; *;
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作者单位

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年(卷),期 2007(1),1
年度 2007
页码 8–11
总页数 4
原文格式 PDF
正文语种
中图分类外科学;
关键词
lumbar arthroplasty total disc replacement adverse events complications;

机译：腰椎置换术;全椎间盘置换术;不良事件;并发症;

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专利

1. Prospective, randomized, multicenter food and drug administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months. [J] . Delamarter R, Zigler JE, Balderston RA, The Journal of Bone and Joint Surgery. American Volume . 2011,第8期

机译：ProDisc-L全椎间盘置换术与圆周关节置换术治疗两级腰椎退行性椎间盘疾病的前瞻性，随机，多中心食品和药物管理研究装置豁免研究：二十四个月的结果。
2. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. [J] . Blumenthal S, McAfee PC, Guyer RD, Spine . 2005,第14期

机译：一项前瞻性，随机，多中心的美国食品和药物管理局的研究设备豁免研究，采用CHARITE人工椎间盘置换术与腰椎融合术治疗腰总盘：第一部分：临床疗效评估。
3. Cervical Disc Replacement: Are We There Yet? Commentary on an article by Michael E-Janssen, DO, et al.: "ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease. Seven-Year Follow-up of the Prospective Randomized US Food and Drug Administration Investigational Device Exemption Study" [J] . Mendoza-Lattes Sergio The Journal of Bone and Joint Surgery. American Volume . 2015,第21期

机译：颈椎间盘置换术：我们还在那里吗？对Michael E-Janssen，DO等人的一篇文章的评论：“ ProDisc-C全椎间盘置换术与颈前路椎间盘切除术和融合治疗单水平症状性颈椎间盘疾病。美国随机抽样食品的七年随访和药物管理局的研究器械豁免研究”
4. Retrieval Analyses of Dynesys® Polymeric Implants from a United States Investigational Device Exemption Study [C] . Kai Zhang, Ming Shen, John M Dawson Annual meeting of the Society for Biomaterials . 2011

机译：来自美国的研究性器械豁免研究中的Dynesys®聚合物植入物的检索分析
5. Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving US Food and Drug Administration Premarket Approval in 2010 and 2011. [D] . Rathi, Vinay Kumar. 2016

机译：在2010年和2011年获得美国食品药品监督管理局上市前批准的高风险治疗性医疗器械整个产品生命周期中进行的临床研究。
6. Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective Randomized Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc [O] . Richard T. Holt, Mohammed E. Majd, Jorge E. Isaza, 2007

机译：腰椎间盘置换术与融合术相比的并发症：来自美国食品药品监督管理局的前瞻性随机多中心Charité人工椎间盘调查设备豁免研究的结果
7. The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment [O] . Scott L. Blumenthal, Richard D. Guyer, Fred H. Geisler, 2007

机译：在美国食品和药物管理局批准的前18个月在美国延迟替代品：报告了在调查设备豁免学习环境之外的不良事件
8. FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff [R] . 2014

机译：FDa关于研究设备豁免的决定临床调查：赞助商指南，机构审查委员会和食品药品管理局工作人员

The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment

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