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无柄肩关节置换术:现状

Stemless shoulder arthroplasty: current status.

作者信息

Churchill R Sean

机构信息

Aurora Advanced Healthcare, Milwaukee, WI, USA.

出版信息

J Shoulder Elbow Surg. 2014 Sep;23(9):1409-14. doi: 10.1016/j.jse.2014.05.005. Epub 2014 Jul 11.

Abstract

BACKGROUND

Since the original Neer humeral replacement in the 1950s, the standard primary anatomic total shoulder arthroplasty design has slowly evolved. Most recently, the humeral stem has become progressively shorter to help combat stem-related complications. Currently, there are several companies who have developed and marketed a stemless humeral arthroplasty component.

MATERIALS AND METHODS

Manufacturers' data for 5 stemless shoulder arthroplasty components currently on the market were analyzed and reviewed. A literature review of short-term results for stemless shoulder arthroplasty was completed.

RESULTS

Of the stemless shoulder arthroplasty systems available on the market, 3 are currently undergoing clinical trials in the United States. The Tornier Simpliciti (Tornier, Edina, MN, USA) clinical trial began in 2011. The study with 2-year minimum follow-up results is scheduled for completion in November 2014. The Arthrex Eclipse (Arthrex, Naples, FL, USA) clinical trial was started in January 2013. The tentative study completion date is 2017. The Biomet Nano (Biomet, Warsaw, IN, USA) clinical trial began in October 2013 and also has a tentative completion date of 2017. No other clinical trial is currently under way in the United States. Early results for stemless shoulder arthroplasty indicate clinical results similar to standard stemmed shoulder arthroplasty. Radiographic analysis indicates implant stability without migration or subsidence at 2- to 3-year minimum follow-up..

CONCLUSIONS

Several stemless shoulder arthroplasty implants are available outside the United States. Early clinical and radiographic results are promising, but well-designed clinical studies and midterm results are lacking. Three clinical trials are currently under way in the United States with initial availability for use anticipated in 2015.

摘要

背景

自20世纪50年代首次出现Neer肱骨置换术以来,标准的初次解剖型全肩关节置换术设计一直在缓慢发展。最近,肱骨干逐渐变短以帮助应对与假体柄相关的并发症。目前,有几家公司已研发并销售无柄肱骨头置换假体。

材料与方法

分析并回顾了目前市场上5种无柄肩关节置换假体的制造商数据。完成了关于无柄肩关节置换术短期结果的文献综述。

结果

市场上现有的无柄肩关节置换系统中,有3种目前正在美国进行临床试验。Tornier Simpliciti(美国明尼苏达州伊登市的Tornier公司)的临床试验于2011年开始。这项至少随访2年结果的研究计划于2014年11月完成。Arthrex Eclipse(美国佛罗里达州那不勒斯市的Arthrex公司)的临床试验于2013年1月启动。暂定的研究完成日期为2017年。Biomet Nano(美国印第安纳州华沙市的Biomet公司)的临床试验于2013年10月开始,暂定完成日期也是2017年。美国目前没有其他正在进行的临床试验。无柄肩关节置换术的早期结果表明其临床结果与标准有柄肩关节置换术相似。影像学分析表明,在至少随访2至3年时,植入物稳定,无移位或下沉。

结论

在美国以外有几种无柄肩关节置换植入物可供使用。早期的临床和影像学结果很有前景,但缺乏设计良好的临床研究和中期结果。美国目前正在进行三项临床试验,预计2015年可首次投入使用。

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