Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes.
Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes.
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DOI：
10.3109/17453674.2015.1074483
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发表时间：
2015
影响因子：
3.7
通讯作者：
Blom AW
中科院分区：
文献类型：
--
作者：
Tucker K;Pickford M;Newell C;Howard P;Hunt LP;Blom AW
背景和目的：最近有一些广为报道的例子表明，一些较新的假体设计用于全髋关节置换术的效果不佳。这引发了加强监管的呼声。然而，外科医生并不总是遵守现有的规定，经常使用不同制造商的植入物来代替髋关节，这违背了药品和保健产品监管机构（MHRA）的建议和制造商的指示。患者和方法-我们使用来自英格兰和威尔士国家联合登记处（NJR）的数据来调查这种做法。结果-混合成分很常见，我们确定了2003年至2013年间记录的9万多例病例。在大多数情况下（48,156），一个制造商的柄和头与另一个制造商的聚乙烯胶结杯混合。当使用胶结柄和聚乙烯杯时，将一个制造商的柄与另一个制造商的杯混合使用可以降低矫正率。在8年时，混合组的累计修订百分比为1.9% (95% CI: 1.7-2.1)，而匹配组为2.4% (2.3-2.5)（p = 0.001）。一个制造商的头和另一个制造商的茎的混合与更高的修订率相关（p < 0.001）。在使用陶瓷对陶瓷或金属对金属轴承的髋关节置换术中，混合使用不同制造商的柄、头和杯具有相似的翻修率（p > 0.05）。解释-混合来自不同制造商的组件是一种常见的做法，尽管它违反了监管指导。然而，除非不同制造商的头和茎一起使用，否则不会增加修改率。
Background and purpose — There have recently been highly publicized examples of suboptimal outcomes with some newer implant designs used for total hip replacement. This has led to calls for tighter regulation. However, surgeons do not always adhere to the regulations already in place and often use implants from different manufacturers together to replace a hip, which is against the recommendations of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the directions of the manufacturers. Patients and methods — We used data from the National Joint Registry of England and Wales (NJR) to investigate this practice. Results — Mixing of components was common, and we identified over 90,000 cases recorded between 2003 and 2013. In the majority of these cases (48,156), stems and heads from one manufacturer were mixed with polyethylene cemented cups from another manufacturer. When using a cemented stem and a polyethylene cup, mixing of stems from one manufacturer with cups from another was associated with a lower revision rate. At 8 years, the cumulative percentage of revisions was 1.9% (95% CI: 1.7–2.1) in the mixed group as compared to 2.4% (2.3–2.5) in the matched group (p = 0.001). Mixing of heads from one manufacturer with stems from another was associated with a higher revision rate (p < 0.001). In hip replacements with ceramic-on-ceramic or metal-on-metal bearings, mixing of stems, heads, and cups from different manufacturers was associated with similar revision rates (p > 0.05). Interpretation — Mixing of components from different manufacturers is a common practice, despite the fact that it goes against regulatory guidance. However, it is not associated with increased revision rates unless heads and stems from different manufacturers are used together.