Reoperations in Cervical Total Disc Replacement Compared With Anterior Cervical Fusion Results Compiled From Multiple Prospective Food and Drug Administration Investigational Device Exemption Trials Conducted at a Single Site
Reoperations in Cervical Total Disc Replacement Compared With Anterior Cervical Fusion Results Compiled From Multiple Prospective Food and Drug Administration Investigational Device Exemption Trials Conducted at a Single Site
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颈椎全椎间盘置换术与颈椎前路融合术的再手术次数比较 在单一地点进行的多项前瞻性食品与药物管理局研究性设备豁免试验结果汇编
DOI：
10.1097/brs.0b013e31828ce774
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发表时间：
2013-06-15
期刊：
影响因子：
3
通讯作者：
Zigler, Jack E.
中科院分区：
文献类型：
--
作者：
Blumenthal, Scott L.;Ohnmeiss, Donna D.;Zigler, Jack E.
研究设计.这项研究是基于对在同一地点进行的多项前瞻性随机研究收集的数据进行事后分析。本研究的目的是比较颈椎全椎间盘置换术（TDR）与颈椎前路融合术（ACF）患者的再手术率。任何新技术的一个重要评估是安全性，包括未来手术的需要。与ACF相比，颈椎TDR的潜在受益之一是可以减少或消除相邻节段的退变。同样重要的是要确定新技术是否引入了新的问题，而不是与当前的护理标准。前瞻性收集了在一家临床试验机构进行的6项美国食品药品监督管理局监管的试验用器械豁免试验中1项试验入组患者的数据。结果基于136例患者（84例TDR，52例ACF），平均随访时间为55.1个月（范围：24-98个月）。收集的数据包括一般人口统计学资料、手术详情、随访时间、再次手术的发生率、再次手术的原因、首次研究手术与再次手术之间的时间长度。在本研究中，再次手术定义为涉及颈椎的任何外科手术。比较TDR组和ACF组的再手术率以及首次手术后再手术发生的时间。TDR组的再手术率明显低于ACF组（8.3% vs.21.2%; P < 0.05）。TDR组因相邻节段退变导致的再手术率明显低于ACF组（4.8% vs. 13.5%; 0.05 < P < 0.07）。在ACF组中，4例患者（7.7%）因假关节再次手术。当比较首次手术和后续手术的平均月数时，TDR组的再手术发生率明显晚于融合组（P < 0.01）。Kaplan-Meier生存分析显示TDR组再次手术前生存期明显长于ACF组（P < 0.05）。本研究发现，TDR组的再手术率明显低于ACF组，TDR组的再手术生存时间更长。与ACF相比，随机分配至TDR组的患者因相邻节段变化而再次手术的频率较低，发生时间较晚。
Study Design. This study is based on a post hoc analysis of data collected from multiple prospective, randomized studies conducted at the same site.Objective. The purpose of this study was to compare the reoperation rates in patients with cervical total disc replacement (TDR) versus patients with anterior cervical fusion (ACF).Summary of Background Data. One important evaluation of any new technology is the safety, including the need for future surgery. One of the potential benefits of cervical TDR compared with ACF, is the possibility of reducing or eliminating degeneration of the adjacent segment. It is also important to determine if the new technology introduces new problems, not seen with the current standard of care.Methods. Data were collected prospectively for patients enrolled in 1 of 6 Food and Drug Administration regulated investigational device exemption trials conducted at a single site. Results are based on 136 patients (84 TDR, 52 ACF) with mean follow-up of 55.1 months (range, 24-98 mo). Data collected included general demographics, operative details, length of follow-up, the occurrence of a reoperation, the reason for the reoperation, length of time between the index study procedure and reoperation. For this study, reoperation was defined as any surgical procedure involving the cervical spine. The reoperation rates as well as the length of time after the index surgery the reoperation occurred were compared for the TDR and ACF groups.Results. The reoperation rate in the TDR group was significantly less than in the ACF group (8.3% vs. 21.2%; P < 0.05). There was a trend for the reoperation rate attributed to adjacent segment degeneration to be significantly less in the TDR group than in the ACF group (4.8% vs. 13.5%; 0.05 < P < 0.07). In the ACF group, 4 patients (7.7%) underwent reoperation for pseudoarthrosis. Reoperations occurred significantly later in the TDR group versus the fusion group when comparing the mean number of months between index and subsequent procedures (P < 0.01). Kaplan-Meier survival analysis also found that the TDR group had a significantly longer survival period before undergoing reoperation than ACF (P < 0.05).Conclusion. This study found the reoperation rate was significantly less in the TDR group compared with ACF group and that the survival time to reoperation was greater in the TDR group. Reoperations for adjacent segment changes were less frequent and occurred later in patients who were randomized to TDR compared with ACF.