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[各种聚甲基丙烯酸甲酯骨水泥的体外研究:关节置换术新材料的首次比较]

[In vitro studies on various PMMA bone cements: a first comparison of new materials for arthroplasty].

作者信息

Kock H-J, Huber F-X, Hillmeier J, Jäger R, Volkmann R, Handschin A E, Letsch R, Meeder P-J

机构信息

Klinik für Orthopädische Chirurgie und Unfallchirurgie, Hochtaunus Kliniken gGmbH, Bad Homburg v d H.

出版信息

Z Orthop Unfall. 2008 Jan-Feb;146(1):108-13. doi: 10.1055/s-2007-989334.

Abstract

AIM

Two clinically established PMMA bone cements (Refobacin Palacos R and Palacos R + G) and two newer cements not yet in widespread clinical use (Refobacin Bone Cement R and SmartSet GHV) were tested in vitro for practically relevant differences.

METHODS

The tests included chemical analyses, handling properties and testing according to the ISO standard for PMMA bone cements.

RESULTS

The results obtained indicate clearly that the copolymers used in Refobacin Bone Cement R and SmartSet GHV differ from those used in the Palacos cements. There were also significant differences in viscosity behaviour and waiting time (p < 0.01 for Palacos cements versus Refobacin Bone Cement R) as an expression of different handling properties. The hardening times under ISO 5833 conditions also differed significantly (p < 0.01 and p < 0.05 for Palacos cements compared with Refobacin Bone Cement R and p < 0.01 for Refobacin Bone Cement R compared with SmartSet GHV).

CONCLUSION

In view of these differences in material properties, the clinical data from long-term use of the bone cements Refobacin Palacos R and Palacos R + G cannot be extrapolated to the newly developed PMMA cements Refobacin Bone Cement R and Smart GHV. Before broad clinical use of these cements, prospective clinical studies using RSA or DEXA and, as a second step, statistically powerful prospective comparative studies should be performed. Until these data are available, patients in whom Refobacin Bone Cement R and SmartSet GHV are used should be informed that the material employed deviates from the standard procedures for cemented joint replacement in the Scandinavian arthroplasty registers and that the long-term consequences cannot, in the final instance, be foreseen. This is essential in order to avoid later malpractice claims on the grounds of inadequate information.

摘要

目的

对两种临床常用的聚甲基丙烯酸甲酯(PMMA)骨水泥(利福平帕拉科斯R骨水泥和帕拉科斯R+G骨水泥)以及两种尚未广泛应用于临床的新型骨水泥(利福平骨水泥R和SmartSet GHV骨水泥)进行体外测试,以找出实际存在的差异。

方法

测试包括化学分析、操作性能以及按照PMMA骨水泥的ISO标准进行测试。

结果

所获结果清楚表明,利福平骨水泥R和SmartSet GHV骨水泥中使用的共聚物与帕拉科斯骨水泥中使用的共聚物不同。作为不同操作性能的一种表现,在粘度行为和等待时间方面也存在显著差异(帕拉科斯骨水泥与利福平骨水泥R相比,p<0.01)。在ISO 5833条件下的固化时间也有显著差异(帕拉科斯骨水泥与利福平骨水泥R相比,p<0.01和p<0.05;利福平骨水泥R与SmartSet GHV骨水泥相比,p<0.01)。

结论

鉴于这些材料性能上的差异,长期使用利福平帕拉科斯R骨水泥和帕拉科斯R+G骨水泥所获得的临床数据不能外推至新开发的PMMA骨水泥利福平骨水泥R和Smart GHV骨水泥。在这些骨水泥广泛应用于临床之前,应进行使用RSA或DEXA的前瞻性临床研究,其次,应进行具有统计学效力的前瞻性对比研究。在获得这些数据之前,应告知使用利福平骨水泥R和SmartSet GHV骨水泥的患者,所使用的材料不同于斯堪的纳维亚关节置换登记中骨水泥型关节置换的标准程序,且最终无法预见其长期后果。这对于避免日后因信息不足而引发医疗事故索赔至关重要。

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