Texas Back Institute, Plano, Texas 75093, USA.
Spine (Phila Pa 1976). 2013 Jun 15;38(14):1177-82. doi: 10.1097/BRS.0b013e31828ce774.
This study is based on a post hoc analysis of data collected from multiple prospective, randomized studies conducted at the same site.
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).
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.
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.
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).
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.
本研究基于在同一地点进行的多项前瞻性、随机研究的数据进行了事后分析。
本研究旨在比较颈椎间盘置换术（TDR）与前路颈椎融合术（ACF）患者的再手术率。
任何新技术的重要评估之一是安全性，包括未来手术的需要。与 ACF 相比，颈椎 TDR 的潜在益处之一是有可能减少或消除相邻节段的退化。确定新技术是否引入了当前护理标准未见的新问题也很重要。
数据是为在单个地点进行的 6 项食品和药物管理局监管的研究性设备豁免试验中的 1 项入组的患者前瞻性收集的。结果基于 136 名患者（84 名 TDR，52 名 ACF），平均随访 55.1 个月（范围，24-98 个月）。收集的数据包括一般人口统计学、手术细节、随访时间、再手术的发生、再手术的原因、指数研究手术与再手术之间的时间。对于本研究，再手术定义为涉及颈椎的任何手术程序。比较了 TDR 组和 ACF 组的再手术率以及索引手术后发生再手术的时间。
TDR 组的再手术率明显低于 ACF 组（8.3%比 21.2%；P < 0.05）。TDR 组归因于相邻节段退变的再手术率明显低于 ACF 组的趋势（4.8%比 13.5%；0.05 <P < 0.07）。在 ACF 组中，4 名患者（7.7%）因假关节形成而行再手术。比较指数和后续手术之间的平均月份数，TDR 组的再手术时间明显晚于融合组（P < 0.01）。Kaplan-Meier 生存分析还发现，TDR 组再手术前的生存时间明显长于 ACF 组（P < 0.05）。
本研究发现 TDR 组的再手术率明显低于 ACF 组，并且 TDR 组的再手术时间更长。与 ACF 相比，随机分配到 TDR 的患者发生相邻节段变化的再手术频率较低，且发生时间较晚。
2 级。
