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Total disc replacement in the cervical spine: a systematic review evaluating long-term safety

机译:颈椎椎间盘全盘置换:评估长期安全性的系统评价

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摘要

>Study design: Systematic review.>Clinical questions: What are the rates and causes of subsequent surgeries? What is the long-term complication rates following cervical artificial disc replacement (C-ADR)? How do these rates change over time?>Methods: A systematic review was undertaken for articles published up to October 2011. Electronic databases and reference lists of key articles were searched to identify comparative and non-comparative studies reporting long-term (≥ 48 months) complications of C-ADR. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus.>Results: Two RCTs reporting outcomes following C-ADR (Bryan disc, Prestige disc) versus anterior cervical discectomy and fusion (ACDF) at follow-ups of 4 to 5 years were found; five case series reporting outcomes following C-ADR at follow-ups of 4 to 8 years were identified. Secondary surgery rates were similar or slightly lower following C-ADR compared with fusion at 4 to 5 years postoperatively. In one small subset of an RCT, rates of adjacent disc heterotopic ossification were lower in C-ADR patients than in those treated with fusion. Rates of other adverse events were similar between treatment groups.>Conclusions: There is low evidence on the long-term safety outcomes following C-ADR. Additional comparative studies with follow-up of at least 4 years are needed to fully understand the long-term safety outcomes of C-ADR compared with fusion.
机译:>研究设计:系统评价。>临床问题 subsequent后续手术的发生率和原因是什么?颈椎间盘置换术(C-ADR)后的长期并发症发生率是多少?这些费率如何随时间变化?>方法:对截至2011年10月发表的文章进行了系统的审查。检索了电子数据库和关键文章的参考文献列表,以鉴定报告时间较长的比较研究和非比较研究-ADR足月(≥48个月)并发症。两名独立审稿人使用GRADE标准评估了证据的强度,并通过共识解决了分歧。>结果:两名RCT报告了C-ADR(Bryan盘,Prestige盘)与颈前路椎间盘切除术和融合术( ACDF)的随访时间为4到5年;在4到8年的随访中,确定了C-ADR后的5个病例系列报告结果。与术后4至5年的融合术相比,C-ADR后的二次手术率相近或略低。在RCT的一小部分中,C-ADR患者的椎间盘异位骨化率低于融合治疗的患者。治疗组之间其他不良事件的发生率相似。>结论: CC-ADR后长期安全性结果证据不足。需要进行至少4年的随访研究,以充分了解C-ADR与融合治疗相比的长期安全性。

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