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植入物品牌组合、数据伪装的可能性以及骨科数据评估小组在全膝关节置换术中的作用。

Implant brand portfolios, the potential for camouflage of data, and the role of the Orthopaedic Data Evaluation Panel in total knee arthroplasty.

作者信息

Phillips Jonathan Robert Anthony, Tucker Keith

机构信息

Exeter Knee Reconstruction Unit, Royal Devon and Exeter Hospital, Exeter, UK.

Orthopaedic Data Evaluation Panel, UK.

出版信息

Bone Joint J. 2021 Oct;103-B(10):1555-1560. doi: 10.1302/0301-620X.103B10.BJJ-2021-0284.R1.

Abstract

AIMS

Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations.

METHODS

Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated.

RESULTS

A simple knee portfolio with cemented cruciate-retaining (CR) and posterior-stabilized (PS) components, with and without a patella, has four combinations. If there are two options available for each component, the numbers double for each option, resulting in 32 combinations. The effect of adding a third option multiplies the number by 1.3. Introducing compatible uncemented options, with the effect of hybrids, multiplies the number by 4. An implant portfolio with two femoral components (both in CR and PS), with two insert options and a patella, all in cemented and uncemented versions leads to 192 possible compatible implant construct combinations. There are implant brands available to surgeons with many more than two options.

CONCLUSION

This study demonstrates that the addition of multiple variants within a knee brand portfolio leads to a large number (many hundreds) of compatible implant construct combinations. Revision rates of implant combinations are not currently reviewed at this level of granularity, leading to the risk of camouflage of true outcomes. Cite this article:  2021;103-B(10):1555-1560.

摘要

目的

膝关节置换手术是治疗膝关节关节炎和疾病的一种非常有效的方法。外科医生可选择的膝关节置换植入物品牌和类型多种多样。由于一些广为人知的失败案例,在英国和许多其他国家,通过国家登记处对关节置换手术进行了严格监管,这些登记处用于监测植入物性能、外科医生和医院。随着时间的推移,许多品牌产品组合中的选择不断增加,出现了替代的胫骨或股骨部件、胫骨插入物材料、形状以及髌骨表面置换。在本研究中,我们调查了植入物品牌产品组合扩展的影响以及品牌名称周围可能存在的透明度不足问题。我们还旨在确定兼容的植入物结构组合的潜在数量。

方法

提出假设的植入物品牌产品组合,并计算兼容的植入物结构组合的数量。

结果

一个简单的膝关节产品组合,包括骨水泥固定的保留交叉韧带(CR)和后稳定(PS)组件,有或没有髌骨,有四种组合。如果每个组件有两种选择,那么每种选择的组合数量会翻倍,从而产生32种组合。增加第三种选择的效果会使组合数量乘以1.3。引入兼容的非骨水泥选项以及混合选项的效果会使组合数量乘以4。一个包含两种股骨组件(CR和PS)、两种插入物选项和一个髌骨的植入物产品组合,所有组件都有骨水泥固定和非骨水泥固定版本,会产生192种可能的兼容植入物结构组合。外科医生可选择的植入物品牌有两种以上选择的情况更多。

结论

本研究表明,膝关节品牌产品组合中增加多个变体导致大量(数百种)兼容的植入物结构组合。目前尚未在这种精细程度上审查植入物组合的翻修率,这导致真实结果被掩盖的风险。引用本文:2021;103 - B(10):1555 - 1560。

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