在 FDA 批准后，与前路颈椎融合术相比，颈椎人工椎间盘置换的使用趋势：新技术的采用。
Utilization trends of cervical artificial disc replacement after FDA approval compared with anterior cervical fusion: adoption of new technology.
机构信息
From the Leni and Peter W. May Department of Orthopaedic Surgery, Mount Sinai Medical Center, New York, NY.
出版信息
Spine (Phila Pa 1976). 2014 Feb 1;39(3):249-55. doi: 10.1097/BRS.0000000000000113.
STUDY DESIGN
Epidemiologic study.
OBJECTIVE
To compare the utilization of anterior cervical discectomy and fusion (ACDF) versus cervical disc arthroplasty (CDA) in terms of patient and hospital characteristics during the 3 years after Food and Drug Administration (FDA) approval of CDA devices in 2007.
SUMMARY OF BACKGROUND DATA
There was a surge in CDA adoption in the 3 years prior to FDA approval of CDA devices in 2007. However, utilization trends of CDA versus ACDF since the FDA approval are unknown.
METHODS
The Nationwide Inpatient Sample database was used to identify CDA and ACDF procedures performed in the United States in the 3 years after FDA approval of CDA devices (2008-2010). The frequencies of CDA and ACDF were estimated, stratified by patient and hospital characteristics. Average length of hospital stay and total charges and costs were estimated. Multivariable analysis was performed to identify patient and hospital characteristics associated with CDA utilization.
RESULTS
In the 3 years after FDA approval of cervical disc devices, population-adjusted growth rates for CDA and ACDF were 4.9% and 11.8%, respectively (P = 0.6977). Female, African American and Medicaid patients were less likely to receive CDA. CDA was less likely to be performed in patients with cervical spondylotic changes and more likely to be performed in younger and healthier patients. CDA was less likely to be performed in the Midwestern United States or in public hospitals.
CONCLUSION
The prevalence of CDA increased in the 3 years after FDA approval with a growth rate that is approximately twice than that for ACDF. Although there seems to be CDA adoption, CDA growth seemed to have reached a plateau and ACDF still remained the dominant surgical strategy for cervical disc disease. Possible regional, racial, and sex disparities in CDA utilization and a more strict approach in the selection of CDA over traditional ACDF may have impeded rapid adoption of CDA.
LEVEL OF EVIDENCE
研究设计
流行病学研究。
目的
在 2007 年食品和药物管理局 (FDA) 批准颈椎间盘置换 (CDA) 装置后 3 年内，比较颈椎前路椎间盘切除融合术 (ACDF) 与 CDA 在患者和医院特征方面的应用。
背景资料概要
在 2007 年 FDA 批准 CDA 装置之前的 3 年内，CDA 的应用出现了激增。然而，自 FDA 批准以来，CDA 与 ACDF 的使用趋势尚不清楚。
方法
使用全国住院患者样本数据库，在美国 FDA 批准 CDA 装置后的 3 年内确定在美国进行的 CDA 和 ACDF 手术。按患者和医院特征对 CDA 和 ACDF 的频率进行估计。估计平均住院时间和总费用。进行多变量分析，以确定与 CDA 使用相关的患者和医院特征。
结果
在 FDA 批准颈椎间盘装置后的 3 年内，CDA 和 ACDF 的人口调整增长率分别为 4.9%和 11.8%（P = 0.6977）。女性、非裔美国人和医疗补助患者接受 CDA 的可能性较小。CDA 较少用于患有颈椎退行性改变的患者，而更多地用于年轻和健康的患者。CDA 较少在美国中西部地区或公立医院进行。
结论
在 FDA 批准后的 3 年内，CDA 的应用率有所增加，增长率约为 ACDF 的两倍。尽管 CDA 的应用似乎有所增加，但 CDA 的增长似乎已经达到了一个平台期，ACDF 仍然是治疗颈椎间盘疾病的主要手术策略。CDA 应用方面可能存在区域性、种族和性别差异，以及在选择 CDA 而不是传统 ACDF 时更加严格的方法，可能阻碍了 CDA 的快速采用。
证据水平
3 级。
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