Tucker Keith, Pickford Martin, Newell Claire, Howard Peter, Hunt Linda P, Blom Ashley W
a 1 Spire Hospital Norwich , Norwich.
b 2 Craneswater Consulting , Locks Heath.
Acta Orthop. 2015;86(6):671-7. doi: 10.3109/17453674.2015.1074483. Epub 2015 Sep 1.
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.
We used data from the National Joint Registry of England and Wales (NJR) to investigate this practice.
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).
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.
近期，一些用于全髋关节置换的新型植入物设计出现了不理想的结果，这些案例受到了高度关注。这引发了加强监管的呼声。然而，外科医生并非总是遵守现有的规定，经常将不同制造商生产的植入物混合使用来置换髋关节，这违反了药品和医疗产品监管局（MHRA）的建议以及制造商的指示。
我们使用了英格兰和威尔士国家关节注册中心（NJR）的数据来调查这种做法。
部件混合的情况很常见，我们在2003年至2013年间识别出超过90000例记录案例。在这些案例中的大多数（48156例）中，一个制造商的柄和头与另一个制造商的聚乙烯骨水泥杯混合使用。当使用骨水泥柄和聚乙烯杯时，一个制造商的柄与另一个制造商的杯混合使用与较低的翻修率相关。在8年时，混合组的累积翻修百分比为1.9%（95%置信区间：1.7 - 2.1），而匹配组为2.4%（2.3 - 2.5）（p = 0.001）。一个制造商的头与另一个制造商的柄混合使用与较高的翻修率相关（p < 0.001）。在陶瓷对陶瓷或金属对金属轴承的髋关节置换中，不同制造商的柄、头和杯混合使用与相似的翻修率相关（p > 0.05）。
尽管不同制造商的部件混合使用违反了监管指导，但这种做法很常见。然而，除非不同制造商的头和柄一起使用，否则它与翻修率增加无关。
