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日本单层子宫椎间盘全置换的早期病例-使用注册数据进行短期安全评估

Kurando Utagawa¹, Toshitaka Yoshii¹, Hiroshi Taneichi²

¹Department of Orthopaedic Surgery, Graduate School, Institute of Science Tokyo, Tokyo, Japan.

Spine surgery and related research

|October 17, 2025

概括

全盘更换 (TDR) 在日本早期使用中显示出低并发症率. 这项研究发现,TDR对于单级手术是安全的,术前和两年术后问题很少.

科学领域:

脊柱外科手术脊柱外科手术
整形外科手术整形外科手术
生物材料和植入物生物材料和植入物

背景情况:

使用Mobi-C®和Prestige LP®的全盘替换 (TDR) 在2017年在日本获得批准.
建立了日本的TDR指南和注册系统,以确保有效的手术结果和监控安全.
这项研究评估了单级TDR在日本批准后早期的短期安全性.

研究的目的:

通过使用全国性的注册表来评估与单级TDR相关的并发症.
评估TDR在早期营销后监测期间的短期安全性和并发症率.
分析术前和两年术后的并发症和重新手术率.

主要方法:

分析来自日本全国单级TDR程序注册表的数据.
包括患者特征,手术细节,并发症和重复手术.
在住院期间和出院后2年内评估并发症和重新手术率.

主要成果:

招募了332名患者;271人完成了为期2年的随访.
术后并发症包括血瘤 (1.1%) 和气道阻塞 (0.4%),并进行一次重复手术.
术后并发症 (长达2年) 发生在7.4%的患者中,包括神经症状复发和植入物问题.

结论:

单级TDR显示了相对较低的整体并发症和重新手术率.
这项研究表明,TDR在适当使用时,可以达到有利的结果,并可接受的并发症率.
这些研究结果支持TDR在日本单一水平适应症的短期安全性.

关键词:

宫退行性疾病宫退行性疾病宫全盘替换术宫全盘替换术发生并发症,并发症.全国范围的调查调查调查.

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