Turel Mazda K, Kerolus Mena G, Adogwa Owoicho, Traynelis Vincent C
Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois.
Neurosurg Focus. 2017 Feb;42(2):E2. doi: 10.3171/2016.11.FOCUS16414.
OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)-approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs-Prestige LP, Prestige ST, Bryan, and Secure-C-showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.
目的 本文旨在全面回顾美国食品药品监督管理局（FDA）批准的7种颈椎间盘置换产品的标签，评估其试验开展的具体方法，并对这些产品进行广泛比较，以便每位外科医生能根据具体标签而非已发表的研究，确定哪种椎间盘最适合其特定的治疗目标。方法 从FDA官方网站获取7种人工椎间盘的FDA批准标签。对这些标签在进行的统计分析、安全性和有效性数据以及每种人工椎间盘为获得产品或器械的FDA批准而参与的随机对照试验方面进行细致比较。同时考察了单节段和双节段的批准情况，并评估了主要和次要终点。结果 在单节段组中，7种人工椎间盘中的4种——Prestige LP、Prestige ST、Bryan和Secure-C——在总体成功率方面表现出优势。Prestige ST在4项结局指标中的3项（神经功能成功、翻修手术和总体成功）表现出优势，而上述其他椎间盘在2项或更少指标上表现出优势（Prestige LP，神经功能和总体成功；Bryan，颈部功能障碍指数[NDI]和总体成功；Secure-C，翻修手术和总体成功；Pro-Disc C，翻修手术）。PCM和Mobi-C椎间盘在所有结局指标上显示出非劣效性。在双节段组中，Prestige LP和Mobi-C在3项结局指标（NDI、二次手术和总体成功）上表现出优势，但在神经功能成功方面未表现出优势。结论 本文对美国目前批准并上市的7种人工椎间盘进行了全面分析。将这些器械的特定结局指标与作为治疗标准的前路颈椎间盘切除融合术的指标进行了比较。这些信息将使外科医生有机会轻松回答患者的问题，并在与制造商讨论器械时保持知识渊博。
