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第二代运动引导全膝关节系统的短期安全性和有效性

Short-term safety and effectiveness of a second-generation motion-guided total knee system.

作者信息

Harris Adam I, Luo Tianyi David, Lang Jason E, Kopjar Branko

机构信息

San Antonio Orthopaedic Specialists, San Antonio, TX, USA.

Physician Scientist Training Program, Wake Forest Baptist Medical Center, Department of Orthopaedic Surgery, Winston-Salem, NC, USA.

出版信息

Arthroplast Today. 2018 Feb 16;4(2):240-243. doi: 10.1016/j.artd.2017.11.007. eCollection 2018 Jun.

DOI:10.1016/j.artd.2017.11.007
PMID:29896561
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5994596/
Abstract

BACKGROUND

Modern knee prostheses are designed to more closely replicate normal knee kinematics. The JOURNEY II Bi-Cruciate Stabilized Total Knee System (Smith & Nephew Inc., Memphis, TN) is a second-generation motion-guided knee system that demonstrates axial rotation patterns during flexion, which resemble those of the normal knee. The aim of this study was to assess the short-term safety and effectiveness of this system in standard clinical practice.

METHODS

A total of 186 subjects (209 primary total knee arthroplasties [TKAs]) were enrolled at 12 U.S. sites. Subjects were operated on between December 2011 and October 2013 and followed for 24 months. Radiographic, clinical, and patient-reported outcome data were collected at 6-, 12-, and 24-month postoperatively.

RESULTS

At 24-month follow-up, the average objective Knee Society Score was 96.20 (standard deviation [SD] = 6.63), the average satisfaction score was 35.22 (SD = 6.63), the average expectation score was 10.91 (SD = 3.16), and the average functional activities score was 81.49 (SD = 14.65). On a 0-10 scale, pain level for walking was 0.79 (SD = 1.51) and 1.50 (SD = 1.97) for climbing stairs or inclines. The cumulative incidence of reoperation at 2-year follow-up was 1.48% (95% confidence interval [CI] 0.48%-4.52%). Ten TKAs in 7 patients were treated with closed manipulations for stiffness. Iliotibial band syndrome was reported in 2 TKAs. Two deep infections occurred, 1 requiring reoperation. No dislocations occurred in the study cohort.

CONCLUSIONS

In short-term follow-up, the JOURNEY II Bi-Cruciate Stabilized Guided Motion Total Knee System appears to be a safe and effective device for TKA.

摘要

背景

现代膝关节假体旨在更精确地模拟正常膝关节的运动学。JOURNEY II双交叉韧带稳定型全膝关节系统(史赛克公司,田纳西州孟菲斯)是第二代运动引导型膝关节系统,在屈曲过程中展现出与正常膝关节相似的轴向旋转模式。本研究的目的是评估该系统在标准临床实践中的短期安全性和有效性。

方法

在美国的12个地点共纳入了186名受试者(209例初次全膝关节置换术[TKA])。受试者于2011年12月至2013年10月接受手术,并随访24个月。在术后6个月、12个月和24个月收集影像学、临床和患者报告的结局数据。

结果

在24个月的随访中,膝关节协会平均客观评分为96.20(标准差[SD]=6.63),平均满意度评分为35.22(SD=6.63),平均期望评分为10.91(SD=3.16),平均功能活动评分为81.49(SD=14.65)。在0至10分的评分标准下,行走时的疼痛程度为0.79(SD=1.51),爬楼梯或爬坡时为1.50(SD=1.97)。2年随访时再次手术的累积发生率为1.48%(95%置信区间[CI]0.48%-4.52%)。7例患者中的10例TKA因僵硬接受了闭合手法治疗。2例TKA报告了髂胫束综合征。发生了2例深部感染,其中1例需要再次手术。研究队列中未发生脱位。

结论

在短期随访中,JOURNEY II双交叉韧带稳定型引导运动全膝关节系统似乎是一种用于TKA的安全有效的装置。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dab5/5994596/66be3550f8f7/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dab5/5994596/66be3550f8f7/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dab5/5994596/66be3550f8f7/gr1.jpg

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