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全膝关节置换术中使用钛植入物是否更好?一项随机对照研究。

Is a Titanium Implant for Total Knee Arthroplasty Better? A Randomized Controlled Study.

机构信息

Department of Orthopedic Surgery, Hanil General Hospital, Seoul, South Korea.

Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.

出版信息

J Arthroplasty. 2021 Apr;36(4):1302-1309. doi: 10.1016/j.arth.2020.11.010. Epub 2020 Nov 12.

DOI:10.1016/j.arth.2020.11.010
PMID:33349499
Abstract

BACKGROUND

Lighter weight and lower modulus are potential advantages of titanium (Ti) implants over cobalt chrome (CoCr) implants in total knee arthroplasty (TKA). This study was conducted to determine whether Ti implants in TKA resulted in better clinical outcomes and radiologic results.

METHODS

One hundred and eight patients (216 knees) with knee arthritis warranting bilateral primary TKA were randomly allocated to undergo Ti rotating-platform TKA in one knee and CoCr rotating-platform TKA in the contralateral knee. The mean follow-up period was 5.3 years (range, 1-7 years). The weight of Ti implants was one-third lighter than that of CoCr implants (133.9 g vs 390.1 g, P < .01). Clinical outcomes were evaluated using clinical scores, patient preferences (lightness, comfort, naturalness, and satisfaction), gait analysis (kinetic and kinematic data), range of motion, and degree of pain. Radiologic results were evaluated based on the radiolucent line (RLL), degree of medial tibial bone loss, and loosening as seen on X-ray.

RESULTS

No significant differences were observed in clinical scores or patient preference. Regarding implant weight, approximately 70% of patients did not perceive the Ti implant as lighter. No significant differences were observed in gait analysis, range of motion, or degree of pain. The RLL was seen in 9% of the Ti implant group and 19% of the CoCr implant group.

CONCLUSION

The lighter Ti implant did not show any clinical benefit over CoCr implants. The lightness of the Ti implant is not sufficient to matter or be noticeable. However, the Ti implant showed lower rate of RLL than the CoCr implant.

LEVEL OF EVIDENCE

level I, randomized controlled trial.

摘要

背景

在全膝关节置换术(TKA)中,钛(Ti)植入物的重量更轻、弹性模量更低,这可能是其相对于钴铬(CoCr)植入物的优势。本研究旨在确定 TKA 中使用 Ti 植入物是否会带来更好的临床结果和影像学结果。

方法

108 例(216 膝)膝关节关节炎患者需要行双侧初次 TKA,随机分配至一侧膝关节行 Ti 旋转平台 TKA,对侧膝关节行 CoCr 旋转平台 TKA。平均随访时间为 5.3 年(1-7 年)。Ti 植入物的重量比 CoCr 植入物轻三分之一(133.9 g 比 390.1 g,P <.01)。临床结果采用临床评分、患者偏好(轻便、舒适、自然和满意度)、步态分析(动力学和运动学数据)、活动范围和疼痛程度进行评估。影像学结果根据射线照相上的透光线(RLL)、胫骨内侧骨丢失程度和松动程度进行评估。

结果

临床评分或患者偏好无显著差异。关于植入物重量,约 70%的患者未感知到 Ti 植入物较轻。步态分析、活动范围或疼痛程度无显著差异。Ti 植入物组有 9%出现 RLL,CoCr 植入物组有 19%出现 RLL。

结论

与 CoCr 植入物相比,较轻的 Ti 植入物并未显示出任何临床优势。Ti 植入物的轻便程度不足以产生影响或引起注意。然而,Ti 植入物的 RLL 发生率低于 CoCr 植入物。

证据水平

I 级,随机对照试验。

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