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全膝关节置换术后患者结局改善但植入物保留功能:一项随机对照试验的纵向随访。

Reduction in patient outcomes but implant-derived preservation of function following total knee arthroplasty: longitudinal follow-up of a randomized controlled trial.

机构信息

Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh, UK.

出版信息

Bone Joint J. 2020 Apr;102-B(4):434-441. doi: 10.1302/0301-620X.102B4.BJJ-2019-0767.R2.

DOI:10.1302/0301-620X.102B4.BJJ-2019-0767.R2
PMID:32228078
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7133720/
Abstract

AIMS

There are comparatively few randomized studies evaluating knee arthroplasty prostheses, and fewer still that report longer-term functional outcomes. The aim of this study was to evaluate mid-term outcomes of an existing implant trial cohort to document changing patient function over time following total knee arthroplasty using longitudinal analytical techniques and to determine whether implant design chosen at time of surgery influenced these outcomes.

METHODS

A mid-term follow-up of the remaining 125 patients from a randomized cohort of total knee arthroplasty patients (initially comprising 212 recruited patients), comparing modern (Triathlon) and traditional (Kinemax) prostheses was undertaken. Functional outcomes were assessed with the Oxford Knee Score (OKS), knee range of movement, pain numerical rating scales, lower limb power output, timed functional assessment battery, and satisfaction survey. Data were linked to earlier assessment timepoints, and analyzed by repeated measures analysis of variance (ANOVA) mixed models, incorporating longitudinal change over all assessment timepoints.

RESULTS

The mean follow-up of the 125 patients was 8.12 years (7.3 to 9.4). There was a reduction in all assessment parameters relative to earlier assessments. Longitudinal models highlight changes over time in all parameters and demonstrate large effect sizes. Significant between-group differences were seen in measures of knee flexion (medium-effect size), lower limb power output (large-effect size), and report of worst daily pain experienced (large-effect size) favouring the Triathlon group. No longitudinal between-group differences were observed in mean OKS, average daily pain report, or timed performance test. Satisfaction with outcome in surviving patients at eight years was 90.5% (57/63) in the Triathlon group and 82.8% (48/58) in the Kinemax group, with no statistical difference between groups (p = 0.321).

CONCLUSION

At a mean 8.12 years, this mid-term follow-up of a randomized controlled trial cohort highlights a general reduction in measures of patient function with patient age and follow-up duration, and a comparative preservation of function based on implant received at time of surgery. Cite this article: 2020;102-B(4):434-441.

摘要

目的

评估膝关节置换假体的随机研究相对较少,报告长期功能结果的研究则更少。本研究旨在评估一项现有植入物试验队列的中期结果,通过纵向分析技术记录全膝关节置换术后患者功能随时间的变化,并确定手术时选择的植入物设计是否会影响这些结果。

方法

对全膝关节置换患者随机队列中剩余的 125 名患者(最初包括 212 名招募患者)进行中期随访,比较现代(Triathlon)和传统(Kinemax)假体。使用牛津膝关节评分(OKS)、膝关节活动范围、疼痛数字评分量表、下肢功率输出、计时功能评估量表和满意度调查评估功能结果。将数据与早期评估时间点相关联,并通过重复测量方差(ANOVA)混合模型进行分析,该模型纳入了所有评估时间点的纵向变化。

结果

125 名患者的平均随访时间为 8.12 年(7.3-9.4 年)。与早期评估相比,所有评估参数均有所下降。纵向模型突出了所有参数随时间的变化,并显示出较大的效应量。在膝关节屈曲(中效应量)、下肢功率输出(大效应量)和报告的最差日常疼痛(大效应量)方面,两组间存在显著差异,这有利于 Triathlon 组。在平均 OKS、平均每日疼痛报告或计时性能测试方面,未观察到两组间的纵向差异。在 8 年时,存活患者对结果的满意度为 Triathlon 组 90.5%(57/63),Kinemax 组 82.8%(48/58),两组间无统计学差异(p=0.321)。

结论

在平均 8.12 年的随访中,本研究对一项随机对照试验队列的中期结果进行了分析,结果表明,随着患者年龄和随访时间的增加,患者功能的各项测量值普遍下降,但基于手术时植入物的选择,功能得到了相对较好的保留。

引用本文

2020;102-B(4):434-441.

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