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使用聚醚醚酮与传统植入物对全膝关节置换术中胫骨水泥渗透和短期临床结果的影响:一项随机对照试验。

Consequences of using poly-ether-ether-ketone versus traditional implant on tibial cement penetration and short-term clinical outcomes during total knee arthroplasty: a randomized controlled trial.

机构信息

Department of Joint Surgery, Honghui Hospital, Xi'An Jiaotong University, No.555 East Youyi Road, Xi'an, Shanxi, China.

出版信息

J Orthop Surg Res. 2023 Aug 9;18(1):589. doi: 10.1186/s13018-023-04064-1.

Abstract

BACKGROUND

The use of poly-ether-ether-ketone (PEEK) prosthesis during total knee arthroplasty (TKA) is a relatively new concept. Several studies have suggested that the thickness of cement penetration during TKA may affect the stability of the implants. The present study aimed to compare the cement penetration and clinical performance between PEEK and traditional cobalt chromium molybdenum (CoCrMo) prosthesis during TKA.

METHODS

This study was a randomized controlled trial with level I of evidence. A total of 48 patients were randomly assigned to either the PEEK group (n = 24) or the CoCrMo group (n = 24). Mean bone cement penetration under the tibial baseplate was assessed radiographically in four zones in the anteroposterior view and two zones in the lateral view, in accordance with the Knee Society Scoring System. Furthermore, parameters such as the Knee Society Score (KSS), visual analogue scale (VAS) scores, complications and survivorship at 1 year postoperatively were also compared.

RESULTS

According to the results of this study, the mean bone cement penetration exhibited no significant difference between PEEK and CoCrMo groups (2.49 ± 0.61 mm vs. 2.53 ± 0.68 mm, p = 0.85). Additionally, there were no remarkable differences in the KSS clinical score, functional score, and VAS score between the two groups. Moreover, complications and survivorship were also statistically compared between the groups and presented no significant differences.

CONCLUSIONS

Based on the current findings, it can be concluded that PEEK implant present similar bone cement penetration, short-term clinical outcomes, and survivorship with traditional CoCrMo implant in TKA without added complications. Trial registration Chinese Clinical Trial Registry (ChiCTR2100047563).

摘要

背景

在全膝关节置换术(TKA)中使用聚醚醚酮(PEEK)假体是一个相对较新的概念。有几项研究表明,TKA 中骨水泥渗透的厚度可能会影响植入物的稳定性。本研究旨在比较 PEEK 和传统钴铬钼(CoCrMo)假体在 TKA 中的骨水泥渗透和临床性能。

方法

这是一项具有 I 级证据水平的随机对照试验。48 名患者被随机分配到 PEEK 组(n=24)或 CoCrMo 组(n=24)。根据膝关节协会评分系统,在前后位的四个区域和侧位的两个区域,评估胫骨基板下的平均骨水泥渗透。此外,还比较了术后 1 年的膝关节协会评分(KSS)、视觉模拟评分(VAS)、并发症和存活率等参数。

结果

根据本研究的结果,PEEK 和 CoCrMo 组之间的平均骨水泥渗透没有显著差异(2.49±0.61mm vs. 2.53±0.68mm,p=0.85)。此外,两组之间的 KSS 临床评分、功能评分和 VAS 评分也没有显著差异。此外,两组之间的并发症和存活率也进行了统计学比较,没有显著差异。

结论

根据目前的发现,可以得出结论,在 TKA 中,PEEK 植入物与传统的 CoCrMo 植入物具有相似的骨水泥渗透、短期临床结果和存活率,且没有增加并发症。试验注册:中国临床试验注册中心(ChiCTR2100047563)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b88/10410788/abc52edeff9a/13018_2023_4064_Fig1_HTML.jpg

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