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关节面置换植入物召回:一家英国地区医院的经验

The articular surface replacement implant recall: a United Kingdom district hospital experience.

作者信息

Whitwell George S, Shine Ashokan, Young Steve K

机构信息

Department of Orthopaedic Surgery, Warwick Hospital Foundation Trust, Warwickshire, UK.

出版信息

Hip Int. 2012 Jul-Aug;22(4):362-70. doi: 10.5301/HIP.2012.9351.

DOI:10.5301/HIP.2012.9351
PMID:22865254
Abstract

We present our experience of the articular surface replacement (ASR) hip and the implant recall process. One hundred and twenty-one ASR components were implanted (21 resurfacing hip arthroplasty (RHA) and 100 ASR/XL modular total hip replacements). At the time of the implant recall in August 2010 there were 111 surviving hips (92%) with a mean follow-up of 44 months. Nine hips had been revised and one had been listed for revision surgery. Ninety-two percent of surviving implants were reviewed in the recall clinics, and blood metal ion levels or ultrasound scans were indicated in 38 hips (34%). Immediately after the recall process seven hips (6 ASR/XL and 1 RHA) were listed for revision and a further 9 were kept under close surveillance. One year after completion of the recall process 23 hips (19 ASR/XL and 4 RHA's) had been revised. A diagnosis of adverse reaction to metal debris (ARMD) was made at surgery in all but two hips. Our current revision rate for ASR RHA is 19% (mean follow-up 62 months, range 29-80) and for the ASR/XL is 19% (mean follow-up 53 months, range 10-80). The 5-year cumulative survival rates with revision for any reason for the ASR/XL, was 80.8% (95% confidence interval 72.0 - 89.5). Given experience elsewhere we expect this rate may increase significantly with time.

摘要

我们介绍了我们在关节面置换(ASR)髋关节及植入物召回过程中的经验。共植入了121个ASR组件(21例表面置换髋关节成形术(RHA)和100例ASR/XL模块化全髋关节置换)。在2010年8月进行植入物召回时,有111例髋关节存活(92%),平均随访44个月。9例髋关节已进行翻修,1例已列入翻修手术名单。92%的存活植入物在召回诊所接受了检查,38例髋关节(34%)进行了血液金属离子水平检测或超声扫描。召回过程结束后,立即有7例髋关节(6例ASR/XL和1例RHA)被列入翻修名单,另有9例接受密切监测。召回过程结束一年后,23例髋关节(19例ASR/XL和4例RHA)进行了翻修。除2例髋关节外,所有手术中均诊断为金属碎屑不良反应(ARMD)。我们目前ASR RHA的翻修率为19%(平均随访62个月,范围29 - 80个月),ASR/XL的翻修率为19%(平均随访53个月,范围10 - 80个月)。ASR/XL因任何原因进行翻修的5年累积生存率为80.8%(95%置信区间72.0 - 89.5)。根据其他地方的经验,我们预计随着时间推移,这一比率可能会显著提高。

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