Fiani Brian, Nanney Jacob M, Villait Akash, Sekhon Manraj, Doan Thao
Neurosurgery, Desert Regional Medical Center, Palm Springs, USA.
College of Medicine, University of Kentucky, Lexington, USA.
Cureus. 2021 Jul 29;13(7):e16739. doi: 10.7759/cureus.16739. eCollection 2021 Jul.
Spinal disc arthroplasty (SDA) has been a rising alternative to fusion for the treatment of degenerative disc disease (DDD). This review aims to provide an overview of the timeline, approvals, and limitations of SDA through analysis of U.S. Food and Drug Administration (FDA)-approved trials. Clinical studies have shown more successful outcomes when comparing cervical disc arthroplasty (CDA) with anterior cervical decompression and fusion, with the key benefits of decreased risk of nerve root compression and adjacent disc disease. CDA is currently approved by the FDA for one- and two-level disc pathologies. However, there are no approved trials for three-level or more cervical pathologies. The FDA approved its usage for the treatment of one-level lumbar disc pathologies in 2007 and recently approved two-level disc pathologies in 2020. Thoracic SDA has not been approved by the FDA, and there are no currently occurring clinical trials. While multilevel SDA has been approved in the cervical and lumbar spine, it has not been approved in more than two adjacent vertebral levels. Based on these clinical studies, future research is needed to compare the success of SDA for three-level or more disc pathologies. There have been recent publications showing promising results, though no FDA-approved clinical trials exist. Furthermore, a hybrid construct has been a recent surgical method to treat multilevel DDD. In this approach, arthroplasty and fusion techniques are combined in alternating fashion at adjacent levels to treat two- and three-level disc disease. Hybrid arthroplasty compared with SDA is currently being studied in clinical trials. As such, long-term research with FDA-approved clinical trials is needed to understand the benefits and limitations of different approaches in the treatment of DDD.
脊柱椎间盘置换术（SDA）已成为治疗退行性椎间盘疾病（DDD）的一种新兴的融合替代方法。本综述旨在通过分析美国食品药品监督管理局（FDA）批准的试验，概述SDA的发展历程、获批情况及局限性。临床研究表明，与颈椎前路减压融合术相比，颈椎间盘置换术（CDA）的治疗效果更佳，其主要优势在于神经根受压和相邻椎间盘疾病的风险降低。目前，FDA已批准CDA用于治疗单节段和双节段椎间盘病变。然而，尚无针对三节段或更多节段颈椎病变的获批试验。FDA于2007年批准其用于治疗单节段腰椎间盘病变，最近在2020年批准了双节段椎间盘病变。胸椎SDA尚未获得FDA批准，目前也没有正在进行的临床试验。虽然多节段SDA已在颈椎和腰椎获得批准，但尚未在两个以上相邻椎体节段获得批准。基于这些临床研究，需要进一步开展研究，比较SDA治疗三节段或更多节段椎间盘病变的成功率。最近有一些出版物显示了有前景的结果，不过尚无FDA批准的临床试验。此外，混合结构是最近用于治疗多节段DDD的一种手术方法。在这种方法中，置换术和融合技术在相邻节段交替使用，以治疗双节段和三节段椎间盘疾病。目前正在临床试验中研究混合置换术与SDA的比较。因此，需要通过FDA批准的临床试验进行长期研究，以了解不同方法在治疗DDD中的益处和局限性。
