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两种不同设计理念的临床优秀非骨水泥假体的迁移行为:一项随机 RSA 研究的 5 年随访结果。

Migration behaviour of 2 clinically excellent cementless stems with different design rationales: 5-year follow-up of a randomised RSA-study.

机构信息

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

Department of Biomechanical Engineering, Faculty of Mechanical, Maritime and Materials Engineering, Delft University of Technology Delft, The Netherlands.

出版信息

Hip Int. 2022 Nov;32(6):747-758. doi: 10.1177/1120700021995482. Epub 2021 Feb 17.

Abstract

INTRODUCTION

Excellent long-term survival has been reported for both the Taperloc and the Mallory-Head cementless stems. However, little is known about the migration behaviour of these stems which have different design rationales. The purpose of this randomised clinical trial was to compare the migration and clinical outcomes of these stems during 5 years of follow-up.

METHODS

42 consecutive hips in 38 patients scheduled to receive cementless THA were randomised to either a Taperloc or a Mallory-Head stem. Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 26, and 52 weeks, and annually thereafter. Primary outcome was stem migration measured using roentgen stereophotogrammetric analysis (RSA) and secondary outcomes were the Harris Hip Score (HHS) and 36-Item Short-Form Health Survey (SF-36). No patients were lost to follow-up; in 1 patient the THA was removed due to deep infection 3 months postoperatively. In 6 hips migration measurements were not possible due to insufficient marker configuration.

RESULTS

Throughout the follow-up period of 5 years, 3-dimensional migration was comparable between the Taperloc and the Mallory-Head stems (-values > 0.05). However, at the 5-year follow-up point the retroversion of the Mallory-Head stem was 0.9° more than the Taperloc stem ( = 0.04). Initial subsidence and retroversion were respectively as large as 6.8 mm and 3.6° for the Taperloc stem and 5 mm and 3.6° for the Mallory-Head stem. After the first postoperative year, both implants had stabilised. The mean increment of HHS, as well as the SF-36 scores during the 5-year follow-up, were comparable between the 2 stems.

CONCLUSIONS

The excellent long-term survival of both designs was confirmed in this study showing comparable initial migration with subsequent stabilisation. However, the Taperloc design with a flat, wedged geometry showed better rotational stability.

摘要

介绍

Taperloc 和 Mallory-Head 非骨水泥假体均有优异的长期存活率报道。然而,对于具有不同设计理念的这些假体,其迁移行为知之甚少。本随机临床试验的目的是比较这两种假体在 5 年随访期间的迁移和临床结果。

方法

38 例患者中的 42 例连续髋关节接受非骨水泥 THA,随机分为 Taperloc 或 Mallory-Head 组。评估在术前、术后第 2 天、术后 6、12、26 和 52 周以及此后每年进行。主要结果是使用放射立体摄影分析(RSA)测量的假体迁移,次要结果是 Harris 髋关节评分(HHS)和 36 项简短健康调查问卷(SF-36)。无患者失访;1 例患者因术后 3 个月深部感染而去除 THA。由于标记物配置不足,有 6 例髋关节的迁移测量无法进行。

结果

在 5 年的随访期间,Taperloc 和 Mallory-Head 假体的三维迁移无显著差异(P 值>0.05)。然而,在 5 年随访时,Mallory-Head 假体的后倾比 Taperloc 假体多 0.9°(P=0.04)。Taperloc 假体的初始下沉和后倾分别为 6.8mm 和 3.6°,Mallory-Head 假体为 5mm 和 3.6°。术后第 1 年,两种假体均已稳定。5 年随访期间,HHS 的平均增量以及 SF-36 评分在两种假体之间无显著差异。

结论

本研究证实了这两种设计的优异长期存活率,表明初始迁移相似,随后稳定。然而,具有平楔形几何形状的 Taperloc 设计具有更好的旋转稳定性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c3d/9726743/89b56ad6cde2/10.1177_1120700021995482-fig1.jpg

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