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2017年奇特拉詹·S·拉纳瓦特奖:膝关节置换术中的计算机导航能否改善年轻患者的功能结局?一项随机研究。

2017 Chitranjan S. Ranawat Award: Does Computer Navigation in Knee Arthroplasty Improve Functional Outcomes in Young Patients? A Randomized Study.

作者信息

Kim Young-Hoo, Park Jang-Won, Kim Jun-Shik

机构信息

Y.-H. Kim The Joint Replacement Center, Ewha Womans University, SeoNam Hospital, Seoul, Republic of Korea J.-W. Park, J.-S. Kim The Joint Replacement Center, MokDong Hospital, Seoul, Republic of Korea.

出版信息

Clin Orthop Relat Res. 2018 Jan;476(1):6-15. doi: 10.1007/s11999.0000000000000000.

Abstract

BACKGROUND

Proponents of computer-assisted TKA suggest that better alignment of the TKAs will lead to improved long-term patient functional outcome and survivorship of the implants. However, there is little evidence about whether the improved position and alignment of the knee components obtained using computer navigation improve patient function and the longevity of the TKA.

QUESTIONS/PURPOSES: The purpose of this study was to determine whether (1) clinical results; (2) radiographic and CT scan results; and (3) the survival rate of TKA components would be better in patients having computer-assisted TKA than results of patients having TKA without computer-assisted TKA. In addition, we determined whether (4) complication rates would be less in the patients with computer-assisted TKA than those in patients with conventional TKA.

METHODS

We performed a randomized trial between October 2000 and October 2002 in patients undergoing same-day bilateral TKA; in this trial, one knee was operated on using navigation, and the other knee was operated on without navigation. All 296 patients who underwent same-day bilateral TKA during that period were enrolled. Of those, 282 patients (95%) were accounted for at a mean of 15 years (range, 14-16 years). A total of 79% (223 of 282) were women and the mean age of the patients at the time of index arthroplasty was 59 ± 7 years (range, 48-64 years). Knee Society knee score, WOMAC score, and UCLA activity score were obtained preoperatively and at latest followup. Radiographic measurements were performed including femorotibial angle, position of femoral and tibial components, level of joint line, and posterior condylar offset. Aseptic loosening was defined as a complete radiolucent line > 1 mm in width around any component or migration of any component. Assessors and patients were blind to treatment assignment.

RESULTS

The Knee Society knee (92 ± 8 versus 93 ± 7 points; 95% confidence interval [CI], 92-98; p = 0.461) and function scores (80 ± 11 versus 80 ± 11 points; 95% CI, 73-87; p = 1.000), WOMAC score (14 ± 7 versus 15 ± 8 points; 95% CI, 14-18; p = 0.991), range of knee motion (128° ± 9° versus 127° ± 10°; 95% CI, 100-140; p = 0.780), and UCLA patient activity score (6 versus 6 points; 95% CI, 4-8; p = 1.000) were not different between the two groups at 15 years followup. There were no differences in any radiographic parameters of alignment (on radiography or CT scan) between the two groups. The frequency of aseptic loosening was not different between the two groups (p = 0.918). Kaplan-Meier survivorship of the TKA components was 99% in both groups (95% CI, 93-100) at 15 years as the endpoint of revision or aseptic loosening (p = 0.982). Anterior femoral notching was observed in 11 knees (4%) in the computer-assisted TKA group and none in the conventional TKA group (p = 0.046).

CONCLUSIONS

In this randomized trial, with data presented at a minimum of 14 years of followup, we found no benefit to computer navigation in TKA in terms of pain, function, or survivorship. Unless another study at long-term followup identifies an advantage to survivorship, pain, and function, we do not recommend the widespread use of computer navigation in TKA because of its risks (in this series, we observed femoral notching; others have observed pin site fractures) and attendant costs.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

计算机辅助全膝关节置换术(TKA)的支持者认为,TKA更好的对线将带来更好的长期患者功能结局和植入物的生存率。然而,关于使用计算机导航获得的膝关节组件改善的位置和对线是否能改善患者功能和TKA的使用寿命,几乎没有证据。

问题/目的:本研究的目的是确定:(1)临床结果;(2)影像学和CT扫描结果;以及(3)计算机辅助TKA患者的TKA组件生存率是否优于非计算机辅助TKA患者的结果。此外,我们还确定了(4)计算机辅助TKA患者的并发症发生率是否低于传统TKA患者。

方法

我们在2000年10月至2002年10月期间对接受同日双侧TKA的患者进行了一项随机试验;在该试验中,一侧膝关节采用导航进行手术,另一侧膝关节不采用导航进行手术。在此期间接受同日双侧TKA的所有296例患者均被纳入。其中,282例患者(95%)在平均15年(范围14 - 16年)时接受随访。共有79%(282例中的223例)为女性,初次关节置换时患者的平均年龄为59±7岁(范围48 - 64岁)。术前及最新随访时获取膝关节协会膝关节评分、WOMAC评分和加州大学洛杉矶分校(UCLA)活动评分。进行影像学测量,包括股胫角、股骨和胫骨组件的位置、关节线水平以及后髁偏移。无菌性松动定义为任何组件周围宽度>1mm的完整透光线或任何组件的移位。评估者和患者对治疗分配不知情。

结果

在15年随访时,两组之间的膝关节协会膝关节评分(92±8对93±7分;95%置信区间[CI],92 - 98;p = 0.461)和功能评分(80±11对80±11分;95% CI,73 - 87;p = 1.000)、WOMAC评分(14±7对15±8分;95% CI,14 - 18;p = 0.991)、膝关节活动范围(128°±9°对127°±10°;95% CI,100 - 140;p = 0.780)以及UCLA患者活动评分(6对6分;95% CI,4 - 8;p = 1.000)均无差异。两组之间在任何对线的影像学参数(X线摄影或CT扫描)上均无差异。两组之间无菌性松动的频率无差异(p = 0.918)。以翻修或无菌性松动为终点,两组TKA组件在15年时的Kaplan - Meier生存率均为99%(95% CI,93 - 100)(p = 0.982)。计算机辅助TKA组有11例膝关节(4%)观察到股骨前方切迹,传统TKA组未观察到(p = 0.046)。

结论

在这项随机试验中,在至少14年随访的数据中,我们发现在疼痛、功能或生存率方面,计算机导航在TKA中并无益处。除非另一项长期随访研究确定在生存率、疼痛和功能方面有优势,否则我们不建议在TKA中广泛使用计算机导航,因为其存在风险(在本系列中,我们观察到股骨切迹;其他人观察到针道骨折)以及相关成本。

证据水平

I级,治疗性研究。

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