Liebensteiner M, Janda W, Williams A, Pawelka W, Labek G
Orthopädische Universitätsklinik, Medizinische Universität Innsbruck, Osterreich.
Z Orthop Unfall. 2009 Nov-Dec;147(6):683-8. doi: 10.1055/s-0029-1186021. Epub 2009 Oct 9.
By a retrospective assessment of the Boneloc incident, a bone cement which had an inferior outcome in terms of survival rate, the value of published datasets for the detection of inferior outcomes was evaluated.
A structured literature review of English and German peer reviewed journals was conducted. The articles were assessed with respect to revision rate and statements about the product. In a standardised methodology, adjusted for number of cases and follow-up period, the revision rate was calculated. Main goal was to assess the agreement of published information from different datasets.
In the first 4 years after Boneloc had been brought on the market exclusively experimental studies were published, most of which were in favour of the product. In 1995, clinical studies, migration analyses and register-based articles were published. Most of them reported about inferior results, in the same year Boneloc was taken from the market worldwide. Sample-based clinical follow-up studies were not able to contribute to the decision-making process, they were published with a delay of several years and were underpowered from a statistical point of view. All of them published critical statements--after the product had no longer been available on the market for many years. The average revision rate in sample-based studies exceeded the reference value in the Norwegian Arthroplasty Register 7.35-fold. When the inferior results with Boneloc were published, the product had already disappeared from the national markets in Scandinavian countries' operating registers. The central position of orthopaedic scientific societies in the entire outcome monitoring system in these countries seems to be a key factor for success and rapid reaction to identified problems.
Arthroplasty registers and migration analyses have the highest value for the rapid and reliable detection of inferior outcomes in comparative analyses of published articles. Experimental studies did not agree with the performance of the product in a retrospective view, the data cannot be transferred from the estimation of future clinical outcome like survival rates. The involvement of scientific societies in the assessment and dissemination of the results is a key factor to realise potential benefit by an advanced quality monitoring project like arthroplasty registers.
通过对骨水泥Boneloc事件进行回顾性评估（该骨水泥在生存率方面结果较差），评估已发表数据集对于发现不良结果的价值。
对英文和德文同行评审期刊进行结构化文献综述。根据翻修率和关于该产品的陈述对文章进行评估。采用标准化方法，根据病例数和随访期进行调整，计算翻修率。主要目标是评估不同数据集发表信息的一致性。
在Boneloc上市后的头4年，仅发表了实验性研究，其中大多数支持该产品。1995年，发表了临床研究、移位分析和基于登记册的文章。其中大多数报告了较差的结果，同年Boneloc在全球退市。基于样本的临床随访研究未能对决策过程有所帮助，它们延迟数年发表，并且从统计学角度来看效力不足。所有这些研究都是在该产品已在市场上消失多年后才发表批判性陈述。基于样本的研究中的平均翻修率超过挪威关节置换登记册中的参考值7.35倍。当Boneloc的不良结果发表时，该产品已从斯堪的纳维亚国家手术登记册的国内市场消失。在这些国家，骨科科学协会在整个结果监测系统中的核心地位似乎是取得成功并对已发现问题做出快速反应的关键因素。
在对已发表文章的比较分析中，关节置换登记册和移位分析对于快速可靠地发现不良结果具有最高价值。从回顾性角度看，实验性研究与该产品的性能不一致，数据不能从诸如生存率等未来临床结果的估计中进行转换。科学协会参与结果的评估和传播是通过关节置换登记册这样的先进质量监测项目实现潜在益处的关键因素。
