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同一患者中计算机导航与传统膝关节置换术的临床结果:一项前瞻性、随机、双盲、长期研究。

The Clinical Outcome of Computer-Navigated Compared with Conventional Knee Arthroplasty in the Same Patients: A Prospective, Randomized, Double-Blind, Long-Term Study.

作者信息

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

机构信息

1Ewha Womans University School of Medicine, SeoNam Hospital, Seoul, Republic of Korea 2Ewha Womans University School of Medicine, MokDong Hospital, Seoul, Republic of Korea.

出版信息

J Bone Joint Surg Am. 2017 Jun 21;99(12):989-996. doi: 10.2106/JBJS.16.00791.

Abstract

BACKGROUND

The available comparative studies of computer navigation-assisted and conventional knee arthroplasties have short-term follow-up periods. Therefore, the clinical benefits after long-term follow-up are not clear. The purposes of the current long-term study were to compare clinical outcomes, alignment of the knee components, prevalence of aseptic loosening of the components, implant survival, and complications of total knee arthroplasties performed with and without computer navigation.

METHODS

We prospectively compared the results of 162 consecutive patients (324 knees) with osteoarthritis. These patients had computer-navigated knee arthroplasty in 1 knee and knee arthroplasty without computer navigation in the other. Nine men and 153 women were enrolled in the study. At the time of the index arthroplasty, the mean age of these patients was 68.1 years (range, 49 to 81 years). The mean duration of follow-up was 12.3 years (range, 12 to 13 years). Clinical and radiographic follow-up examinations of the patients were performed at 3 months, 1 year after the operation, and every 2 or 3 years thereafter.

RESULTS

The Knee Society knee score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and range of knee motion were not significantly different between the groups preoperatively or at 12.3 years of follow-up. Patient satisfaction at the final follow-up was not significantly different between the groups. There were no significant differences between the groups with respect to the position and loosening of the components at 12.3 years of follow-up. The Kaplan-Meier survivorship, with revision or loosening as the end point, was 100% (95% confidence interval [CI], 94% to 100%) at 12.3 years in both groups. The prevalence of anterior femoral notching was higher in the computer-navigated knee arthroplasty group (5%) than in the conventional knee arthroplasty group (0.6%).

CONCLUSIONS

Clinical function, position, and survivorship of the components were similar between the groups. The only effect of navigation was a negative one, anterior femoral notching. However, comparison of bilateral total knee arthroplasties may dampen the differentiation regarding pain outcomes. Further, the findings of this study are specific to a single navigation and total knee system.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

现有的计算机导航辅助与传统膝关节置换术的比较研究随访期较短。因此,长期随访后的临床益处尚不清楚。本项长期研究的目的是比较计算机导航辅助与非计算机导航辅助全膝关节置换术的临床疗效、膝关节组件的对线情况、组件无菌性松动的发生率、植入物存活率及并发症。

方法

我们前瞻性地比较了162例(324膝)骨关节炎患者的结果。这些患者一侧膝关节接受计算机导航膝关节置换术,另一侧膝关节接受非计算机导航膝关节置换术。研究纳入9名男性和153名女性。在初次置换手术时,这些患者的平均年龄为68.1岁(范围49至81岁)。平均随访时间为12.3年(范围12至13年)。患者在术后3个月、1年以及此后每2或3年进行临床和影像学随访检查。

结果

两组患者术前或随访12.3年时,膝关节协会膝关节评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分以及膝关节活动范围均无显著差异。末次随访时两组患者的满意度无显著差异。随访12.3年时,两组在组件位置和松动方面无显著差异。以翻修或松动为终点,两组在12.3年时的Kaplan-Meier生存率均为100%(95%置信区间[CI],94%至100%)。计算机导航膝关节置换术组的股骨髁间窝前方切迹发生率(5%)高于传统膝关节置换术组(0.6%)。

结论

两组在临床功能、组件位置和存活率方面相似。导航的唯一影响是负面的,即股骨髁间窝前方切迹。然而,双侧全膝关节置换术的比较可能会削弱疼痛结局方面的差异。此外,本研究结果仅适用于单一的导航和全膝关节系统。

证据水平

治疗性I级。有关证据水平的完整描述,请参阅作者指南。

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