Mayo Clinic Neuro-Informatics Laboratory, Mayo Clinic, Rochester, MN 55902, USA; Department of Neurologic Surgery, Mayo Clinic, Rochester, MN 55902, USA; Department of Neurosurgery, Mayo Clinic, 200 First Street Southwest, Rochester, MN, USA.
Mayo Clinic Neuro-Informatics Laboratory, Mayo Clinic, Rochester, MN 55902, USA; Department of Neurologic Surgery, Mayo Clinic, Rochester, MN 55902, USA; Department of Neurosurgery, Mayo Clinic, 200 First Street Southwest, Rochester, MN, USA.
Neurosurg Clin N Am. 2021 Oct;32(4):425-435. doi: 10.1016/j.nec.2021.05.003. Epub 2021 Jul 29.
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.
2007 年，美国食品药品监督管理局（FDA）首次批准颈椎间盘置换术（CTDR）。此后，又有 8 种人工椎间盘获得 FDA 批准用于单节段 CTDR。其中两种也被批准用于 2 节段 CTDR。所有器械的适应证均为 C3 至 C7 节段，适用于因椎间盘突出或对保守治疗无反应的颈椎病引起的神经根病或脊髓病的有症状患者。临床试验表明，与前路颈椎减压融合术相比，CTDR 的总体成功率相当。混合手术和 3 个或更多节段的 CTDR 未获得 FDA 批准。
