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全膝关节置换中对称和非对称胫骨假体 2 年 RSA 迁移结果:一项随机对照试验。

Two-year RSA migration results of symmetrical and asymmetrical tibial components in total knee arthroplasty: a randomized controlled trial.

机构信息

Biomechanics and Imaging Group, Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Bone Joint J. 2021 May;103-B(5):855-863. doi: 10.1302/0301-620X.103B5.BJJ-2020-1575.R2.

Abstract

AIMS

The objective of this study was to compare the two-year migration pattern and clinical outcomes of a total knee arthroplasty (TKA) with an asymmetrical tibial design (Persona PS) and a well-proven TKA with a symmetrical tibial design (NexGen LPS).

METHODS

A randomized controlled radiostereometric analysis (RSA) trial was conducted including 75 cemented posterior-stabilized TKAs. Implant migration was measured with RSA. Maximum total point motion (MTPM), translations, rotations, clinical outcomes, and patient-reported outcome measures (PROMs) were assessed at one week postoperatively and at three, six, 12, and 24 months postoperatively.

RESULTS

A linear mixed-effect model using RSA data of 31 asymmetrical and 38 symmetrical TKAs did not show a difference in mean MTPM migration pattern of the tibial or femoral components. Mean tibial component MTPM at two years postoperative of the asymmetrical TKA design was 0.93 mm and 1.00 mm for the symmetrical design. For the femoral component these values were 1.04 mm and 1.14 mm, respectively. No significant differences were observed in other migration parameters or in clinical and PROM measurements.

CONCLUSION

The TKA design with an asymmetrical tibial component has comparable component migration with the proven TKA with a symmetrical tibial component. This suggests the risk of long-term aseptic loosening of the two designs is comparable. Cite this article:  2021;103-B(5):855-863.

摘要

目的

本研究旨在比较具有非对称胫骨设计的全膝关节置换术(TKA)(Persona PS)和经过验证的具有对称胫骨设计的 TKA(NexGen LPS)的两年移植物迁移模式和临床结果。

方法

进行了一项随机对照放射立体分析(RSA)试验,包括 75 例骨水泥固定后稳定型 TKA。使用 RSA 测量移植物迁移。术后 1 周、3 个月、6 个月、12 个月和 24 个月评估最大总点运动(MTPM)、平移、旋转、临床结果和患者报告的结果测量(PROMs)。

结果

使用 31 例非对称和 38 例对称 TKA 的 RSA 数据的线性混合效应模型未显示胫骨或股骨组件的平均 MTPM 迁移模式存在差异。非对称 TKA 设计的胫骨组件两年后平均 MTPM 为 0.93mm,对称设计为 1.00mm。对于股骨组件,这些值分别为 1.04mm 和 1.14mm。在其他迁移参数或临床和 PROM 测量中未观察到显著差异。

结论

具有非对称胫骨组件的 TKA 设计与经过验证的具有对称胫骨组件的 TKA 具有可比的组件迁移。这表明两种设计发生长期无菌性松动的风险相当。

引用本文

2021;103-B(5):855-863.

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