颈椎间盘置换术(CDA)已被提倡为前路颈椎间盘切除术和融合术(ACDF)的替代方案,具有降低相邻水平椎间盘退变和节段不稳定的风险的潜力。然而,关节成形术的长期不良事件尚未得到充分报道.
调查CDA和ACDF之间的10年随访不良事件发生率。
这项研究是随机的,prospective,多中心研究设备豁免(IDE)试验及其作为批准后研究(PAS)的持续随访。在2002年5月至2004年10月之间,对颈椎间盘病变进行了单级手术。
n=463名患者。
来自自我报告和生理指标的CDA和ACDF的不良事件比较。
在每个评估时间点,询问受试者自上次就诊以来的不良事件;并记录所有不良事件,无论它们是否与手术或设备有关。记录不良事件,分类,分类并评估严重程度和与研究设备和/或外科手术的关系。使用生命表方法进行事件发生时间分析,总结了每种不良事件的10年累积率。使用对数秩检验来比较两个治疗组。
共有242名患者接受CDA,221名患者接受ACDF。在10年的随访中,对54%(130/242)的CDA患者和47%(104/221)的ACDF受试者进行了评估。在长达10年的随访中,CDA组的231例患者(累积率98.4%)和ACDF组的199例患者(累积率98.7%)发生至少一个不良事件。总的来说,10年内所有不良事件的累积率差异无统计学意义(p=0.166).两组癌症患者的以下不良事件的累积发生率没有差异,心血管,死亡,发音困难/吞咽困难,胃肠,感染,泌尿生殖系统,呼吸,植入物移位/松动,植入物错位,颈部和手臂疼痛,神经学,其他疼痛,脊柱事件,术中血管损伤。然而,在CDA组中,由创伤引起的不良事件较多(p=.012),在指数水平上脊柱事件较多(p=.006).ACDF组有明显更多的骨不连事件(p=0.019),和未结合结果未决(p=.034),相邻级别脊柱事件(p=.033),以及属于“其他”类别的事件(p=.015)。
人工颈椎间盘和颈椎前路关节固定术组发生任何不良事件的患者的累积率没有差异。此外,大多数类别的累积率在两组之间也没有差异.
Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.
To investigate the 10-year follow-up adverse events rates between CDA and ACDF.
The study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a postapproval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.
n=463 patients.
Adverse events comparison of CDA and ACDF from self-reported and physiologic measures.
At each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.
A total of 242 patients received CDA and 221 patients received ACDF. At 10-year follow-up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p=.012) and more spinal events at the index level (p=.006). The ACDF group had significantly more nonunion events (p=.019), and nonunion outcome pending (p=.034), adjacent level spinal events (p=.033), and events that fell into the \"other\" category (p=.015).
The cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.