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与前路颈椎融合术相比,在 FDA 研究性器械豁免临床试验期间颈椎人工椎间盘置换的使用趋势。

Utilization trends of cervical artificial disc replacement during the FDA investigational device exemption clinical trials compared to anterior cervical fusion.

机构信息

Department of Orthopaedic Surgery, Mount Sinai Medical Center, 5 East 98 Street, 9th Floor, NY 10029, USA.

出版信息

J Clin Neurosci. 2013 Dec;20(12):1723-6. doi: 10.1016/j.jocn.2013.03.002. Epub 2013 Aug 22.

DOI:10.1016/j.jocn.2013.03.002
PMID:23972533
Abstract

While anterior cervical discectomy and fusion (ACDF) is the gold standard surgical treatment for cervical disc disease, concerns regarding adjacent segment degeneration lead to the development of cervical disc arthroplasty (CDA). This study compares the utilization trends of CDA versus ACDF during the period of the Food and Drug Administration Investigational Device Exemption clinical trials from 2004 to 2007. The Healthcare Cost and Utilization Project Nationwide Inpatient Sample database was used to identify CDA and ACDF procedures performed in the USA between 2004 and 2007. The prevalence of CDA and ACDF procedures was estimated and stratified by age, sex, diagnosis, census region, payor class, and hospital characteristics. The average length of hospital stay, total charges, and costs were also estimated. The number of CDA surgeries significantly increased annually from 2004 to 2007 and mostly took place at urban non-teaching hospitals. There were no regional differences between CDA and ACDF utilization. There was no difference between sex or admission type between CDA and ACDF patients. ACDF patients were older and had more diabetes, hypertension, and chronic obstructive pulmonary disease. CDA patients were more likely to be discharged home and had shorter hospital stays but had a higher rate of deep venous thrombosis than ACDF patients. Significantly more CDA patients had private insurance while more ACDF patients had Medicare. The average cost was higher for ACDF than CDA. While ACDF dominated surgical intervention for cervical disc disease during the trial period, CDA utilization increased at a significantly greater rate suggesting rapid early adoption.

摘要

虽然前路颈椎间盘切除融合术(ACDF)是治疗颈椎间盘疾病的金标准手术治疗方法,但对相邻节段退变的担忧导致了颈椎间盘置换术(CDA)的发展。本研究比较了 2004 年至 2007 年食品和药物管理局研究性设备豁免临床试验期间 CDA 与 ACDF 的使用趋势。使用医疗保健成本和利用项目全国住院样本数据库来确定 2004 年至 2007 年在美国进行的 CDA 和 ACDF 手术。估计并按年龄、性别、诊断、普查区、付款人类别和医院特征对 CDA 和 ACDF 手术的流行率进行分层。还估计了平均住院时间、总费用和费用。CDA 手术的数量从 2004 年到 2007 年每年显著增加,主要发生在城市非教学医院。CDA 和 ACDF 的使用没有地区差异。CDA 和 ACDF 患者之间的性别或入院类型没有差异。ACDF 患者年龄较大,患有更多的糖尿病、高血压和慢性阻塞性肺疾病。CDA 患者更有可能出院,住院时间更短,但深静脉血栓形成的发生率高于 ACDF 患者。CDA 患者拥有私人保险的比例显著高于 ACDF 患者,而 ACDF 患者拥有医疗保险的比例更高。ACDF 的平均费用高于 CDA。虽然 ACDF 在试验期间主导了颈椎间盘疾病的手术干预,但 CDA 的使用以更快的速度增加,这表明早期快速采用。

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