医学
颈椎病
颈部神经根病变
外科
试验装置豁免
食品药品监督管理局
颈椎
风险分析(工程)
替代医学
病理
作者
Mohamad Bydon,Giorgos D. Michalopoulos,Mohammed Ali Alvi,Anshit Goyal,Kingsley Abode-Iyamah
标识
DOI:10.1016/j.nec.2021.05.003
摘要
The first US Food and Drug Administration (FDA) approval for cervical total disc replacement (CTDR) was issued in 2007. Since then, 8 more artificial discs have been granted FDA approval for single-level CTDR. Two of these have also been approved for 2-level CTDR. All devices are indicated for levels C3 to C7 for symptomatic patients with radiculopathy or myelopathy caused by disc herniation or spondylosis unresponsive to conservative management. Trials have shown noninferiority of CTDR compared with anterior cervical decompression and fusion in their overall success. Hybrid surgery and CTDR of 3 or more levels are not FDA approved.
科研通智能强力驱动
Strongly Powered by AbleSci AI