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全膝关节置换术中患者特异性器械与传统器械及计算机导航的比较:一项随机对照试验。

Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial.

作者信息

Yan Chun Hoi, Chiu Kwong Yuen, Ng Fu Yuen, Chan Ping Keung, Fang Christian Xinshuo

机构信息

Department of Orthopaedics and Traumatology, 5/F, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Pokfulam, Hong Kong SAR, China.

出版信息

Knee Surg Sports Traumatol Arthrosc. 2015 Dec;23(12):3637-45. doi: 10.1007/s00167-014-3264-2. Epub 2014 Sep 13.

Abstract

PURPOSE

The current study investigated the accuracy in achieving proper lower limb alignment and individual component positions after total knee arthroplasty (TKA) with 3 different instrumentation techniques. It was hypothesized that patient-specific instruments (PSI) would achieve more accurate lower limb alignment and component positions compared to conventional instruments (CON).

METHODS

Ninety knees in 81 patients were randomized in 1:1:1 ratio into CON, computer navigation (NAV) and PSI groups to receive TKA. The surgical routines were standardized. The lower limb mechanical axis and individual component positions were assessed on standard radiographs. Tourniquet time, operation time and patients' functional scores were documented.

RESULTS

Conventional instruments and PSI were more likely to result in an excessively flexed femoral component (p = 0.001) compared to NAV. Number of outliers in postoperative lower limb alignment, and other components positions in the coronal and sagittal plane showed no statistically significant difference. The mean tourniquet time and operation time was significantly shorter in CON and PSI groups than NAV group (p < 0.001). Four early complications occurred in the PSI group (p = 0.015). At 3-month follow-up, there was no difference in terms of the knee range of motion and patients' function among the 3 groups.

CONCLUSION

No significant radiological and clinical benefit could be demonstrated in using PSI over CON or NAV in TKA. Routine use of PSI is not recommended because of the extra cost and waiting time.

LEVEL OF EVIDENCE

I.

摘要

目的

本研究调查了采用3种不同手术器械技术进行全膝关节置换术(TKA)后实现下肢正确对线和各个组件位置的准确性。研究假设是,与传统器械(CON)相比,患者特异性器械(PSI)能实现更准确的下肢对线和组件位置。

方法

81例患者的90个膝关节按1:1:1比例随机分为CON组、计算机导航(NAV)组和PSI组,接受TKA手术。手术流程标准化。在标准X线片上评估下肢机械轴和各个组件位置。记录止血带使用时间、手术时间和患者功能评分。

结果

与NAV组相比,CON组和PSI组更有可能导致股骨组件过度屈曲(p = 0.001)。术后下肢对线以及冠状面和矢状面其他组件位置的异常值数量无统计学显著差异。CON组和PSI组的平均止血带使用时间和手术时间显著短于NAV组(p < 0.001)。PSI组发生4例早期并发症(p = 0.015)。在3个月随访时,3组之间的膝关节活动范围和患者功能无差异。

结论

在TKA中,使用PSI相比CON或NAV未显示出显著的影像学和临床益处。由于额外成本和等待时间,不建议常规使用PSI。

证据级别

I级

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