Hospital for Special Surgery, Department of Orthopedic Surgery, New York, NY, USA; Northwell Health, Department of Orthopedic Surgery, Great Neck, NY.
Department of Orthopedic Surgery, Rush University, Chicago, IL, USA.
Spine J. 2021 Feb;21(2):265-272. doi: 10.1016/j.spinee.2020.09.005. Epub 2020 Sep 20.
Cervical disc replacement (CDR) has increased in popularity over the past decade based on published outcomes from FDA IDE studies with narrowly defined inclusion and exclusion criteria. A low rate of complications was noted in these studies. The broader complication profile for CDR in widespread clinical practice has yet to be described.
To outline the complications reported to the FDA regarding commonly used CDR products STUDY DESIGN/SETTING: Retrospective database review PATIENT SAMPLE: Nationwide database of reported complications related to CDR products from patients across the country OUTCOME MEASURES: Complications related to CDR METHODS: We queried the MAUDE database and Alternative Summary Reporting (ASR) data files submitted between January 2005 to March 2020. The complications listed for seven FDA-approved CDR implants were analyzed. The entries in the databases were cataloged for complication type, date of entry, source of report, and whether the investigation was "complete". Reports that had too little information to extract relevant data were excluded.
There were 1,517 entries identified in the MAUDE database. After removal of duplicate entries and entries without sufficient information, there were 1,347 entries analyzed. The top five complications were (1) migration of implant (338 entries, 25.2%) (2) insertion problem/failure (312 entries, 23.3%) (3) neck pain (203 entries, 15.2%) (4) heterotopic ossification (108 entries, 8.1%) and (5) radiculopathy (90 entries, 8.1%). The number of analyzed implant-related MAUDE entries and most common implant-related complication for each implant was 209 entries for insertion problem/failure for Mobi-C; 158 entries for migration of implant for ProDisc-C; 154 entries for insertion problem/failure for Bryan cervical disc; 130 entries for migration of implant for Prestige cervical disc; 49 entries for migration of implant for PCM cervical disc; 12 entries for migration of implant for M6 and 10 entries for migration of implant for Secure-C. Only 263 entries (19.5%) were deemed "complete". Most entries were from the manufacturer/company representative/distributor (923 entries, 70%). There were no entries related to cervical disc replacement devices within the ASR data.
The MAUDE database highlights complications related to CDR implants that may not be emphasized in currently published studies. It is important to understand this broad complication profile for CDR to ensure safe utilization of this new technology.
基于 FDA IDE 研究的发表结果，颈椎间盘置换术 (CDR) 在过去十年中越来越受欢迎，这些研究对纳入和排除标准有严格的定义。这些研究中报告的并发症发生率较低。然而，在广泛的临床实践中，CDR 的更广泛的并发症情况仍有待描述。
概述向 FDA 报告的与常用 CDR 产品相关的并发症。
研究设计/设置：回顾性数据库研究。
来自全国各地患者的与 CDR 产品相关的报告并发症的全国性数据库。
在 MAUDE 数据库中确定了 1517 条记录。在去除重复条目和信息不足的条目后，分析了 1347 条记录。顶级五种并发症为：（1）植入物迁移（338 例，25.2%）；（2）植入问题/失败（312 例，23.3%）；（3）颈部疼痛（203 例，15.2%）；（4）异位骨化（108 例，8.1%）；（5）神经根病变（90 例，8.1%）。分析的与植入物相关的 MAUDE 条目数和每种植入物最常见的植入物相关并发症为：Mobi-C 的植入问题/失败为 209 例；ProDisc-C 的植入物迁移为 158 例；Bryan 颈椎间盘的植入问题/失败为 154 例；Prestige 颈椎间盘的植入物迁移为 130 例；PCM 颈椎间盘的植入物迁移为 49 例；M6 的植入物迁移为 12 例；Secure-C 的植入物迁移为 10 例。只有 263 条（19.5%）被认为是“完整的”。大多数条目来自制造商/公司代表/经销商（923 条，70%）。ASR 数据中没有与颈椎间盘置换装置相关的条目。
MAUDE 数据库强调了与 CDR 植入物相关的并发症，这些并发症可能在当前发表的研究中没有得到强调。了解 CDR 的广泛并发症情况对于确保这种新技术的安全使用非常重要。
