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固定和活动平台 Attune 全膝关节置换术在临床结果、疼痛和活动范围方面无差异:一项前瞻性单中心试验。

No difference in clinical outcome, pain, and range of motion between fixed and mobile bearing Attune total knee arthroplasty: a prospective single-center trial.

机构信息

Department of Orthopedics and Trauma, Medical University of Graz, Auenbruggerplatz 5, A-8036, Graz, Austria.

出版信息

BMC Musculoskelet Disord. 2022 May 2;23(1):413. doi: 10.1186/s12891-022-05382-x.

Abstract

BACKGROUND

Despite numerous scientific investigations, the tribological advantages of mobile bearing inserts have not been sustainably confirmed or refuted for modern knee prostheses in clinical studies. The purpose of this study was to compare fixed and mobile bearing inserts in order to draw conclusions regarding clinical benefits.

METHODS

The present prospective single center cohort study of 2 non-randomized stratified groups consisted of 67 patients. All included patients received cemented total knee arthroplasty (Attune®) due to osteoarthritis. 34 patients were treated with a mobile and 33 patients with a fixed insert. The WOMAC score and the Visual Analogue Scale was used for the subjective assessment of success, while the Knee-Society-Score was used considering the Range of Motion for the objective assessment. The subjective and the clinical scores showed improvements for both compared groups postoperatively at 2 years of minimum follow-up.

RESULTS

The overall postoperative results of the WOMAC score, the Knee-Society-Score and the Visual Analogue Scale presented no statistically difference between the compared groups (p > 0,05). The postoperative ROM showed a superior improvement of 13.2° ± 18.4° in the mobile-bearing group versus 4.9° ± 18.4° (p = 0.017) in the fixed-bearing group. The flexion of the knee joint was 114° ± 10.1° for the mobile-bearings and 109.2° ± 7.2° for fixed bearings (p = 0.012).

CONCLUSION

According to the findings, both inserts showed overall promising postoperative results, in terms of objective as well as subjective parameters, without clinically relevant significant differences, except for ROM, which was superior in the mobile bearing group. The present clinical trial has been registered at the ISRCTN registry with the reverence number ISRCTN15117998 on 04/04/2022.

摘要

背景

尽管进行了大量的科学研究,但在临床研究中,对于现代膝关节假体,移动轴承衬垫的摩擦学优势仍未得到持续证实或否定。本研究的目的是比较固定和移动轴承衬垫,以得出关于临床益处的结论。

方法

本前瞻性单中心队列研究包括 67 名非随机分层患者。所有纳入的患者均因骨关节炎接受骨水泥固定膝关节置换术(Attune®)。34 例患者接受了移动衬垫治疗,33 例患者接受了固定衬垫治疗。WOMAC 评分和视觉模拟评分用于成功的主观评估,而膝关节学会评分则用于考虑运动范围的客观评估。在 2 年的最低随访中,所有患者术后主观和临床评分均有改善。

结果

在比较组中,WOMAC 评分、膝关节学会评分和视觉模拟评分的总体术后结果均无统计学差异(p>0.05)。移动衬垫组的术后 ROM 改善明显优于固定衬垫组(13.2°±18.4°比 4.9°±18.4°,p=0.017)。膝关节的屈曲度为移动衬垫组 114°±10.1°,固定衬垫组 109.2°±7.2°(p=0.012)。

结论

根据研究结果,两种衬垫在客观和主观参数方面均显示出总体良好的术后结果,无明显的临床相关差异,但在移动衬垫组的 ROM 方面表现更优。本临床试验已于 2022 年 4 月 4 日在 ISRCTN 注册处注册,注册号为 ISRCTN86401107。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5fd/9063062/de33b9d946ea/12891_2022_5382_Fig1_HTML.jpg

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