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植入物设计对全膝关节置换术后患者预后有影响:一项前瞻性双盲随机对照试验。

Implant design influences patient outcome after total knee arthroplasty: a prospective double-blind randomised controlled trial.

作者信息

Hamilton D F, Burnett R, Patton J T, Howie C R, Moran M, Simpson A H R W, Gaston P

机构信息

University of Edinburgh, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.

出版信息

Bone Joint J. 2015 Jan;97-B(1):64-70. doi: 10.1302/0301-620X.97B1.34254.

DOI:10.1302/0301-620X.97B1.34254
PMID:25568415
Abstract

Total knee arthroplasty (TKA) is an established and successful procedure. However, the design of prostheses continues to be modified in an attempt to optimise the functional outcome of the patient. The aim of this study was to determine if patient outcome after TKA was influenced by the design of the prosthesis used. A total of 212 patients (mean age 69; 43 to 92; 131 female (62%), 81 male (32%)) were enrolled in a single centre double-blind trial and randomised to receive either a Kinemax (group 1) or a Triathlon (group 2) TKA. Patients were assessed pre-operatively, at six weeks, six months, one year and three years after surgery. The outcome assessments used were the Oxford Knee Score; range of movement; pain numerical rating scales; lower limb power output; timed functional assessment battery and a satisfaction survey. Data were assessed incorporating change over all assessment time points, using repeated measures analysis of variance longitudinal mixed models. Implant group 2 showed a significantly greater range of movement (p = 0.009), greater lower limb power output (p = 0.026) and reduced report of 'worst daily pain' (p = 0.003) over the three years of follow-up. Differences in Oxford Knee Score (p = 0.09), report of 'average daily pain' (p = 0.57) and timed functional performance tasks (p = 0.23) did not reach statistical significance. Satisfaction with outcome was significantly better in group 2 (p = 0.001). These results suggest that patient outcome after TKA can be influenced by the prosthesis used.

摘要

全膝关节置换术(TKA)是一种成熟且成功的手术。然而,假体的设计仍在不断改进,以优化患者的功能结局。本研究的目的是确定TKA术后患者的结局是否受所用假体设计的影响。共有212例患者(平均年龄69岁;43至92岁;131例女性(62%),81例男性(32%))纳入一项单中心双盲试验,并随机分为接受Kinemax(第1组)或Triathlon(第2组)TKA。在术前、术后六周、六个月、一年和三年对患者进行评估。所使用的结局评估指标包括牛津膝关节评分、活动范围、疼痛数字评分量表、下肢功率输出、定时功能评估组合以及满意度调查。采用重复测量方差分析纵向混合模型,对所有评估时间点的变化数据进行评估。在三年的随访中,第2组植入物显示出明显更大的活动范围(p = 0.009)、更大的下肢功率输出(p = 0.026)以及“每日最严重疼痛”报告减少(p = 0.003)。牛津膝关节评分(p = 0.09)、“每日平均疼痛”报告(p = 0.57)和定时功能表现任务(p = 0.23)的差异未达到统计学显著性。第2组对结局的满意度明显更高(p = 0.001)。这些结果表明,TKA术后患者的结局可能受所用假体的影响。

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