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临床试验/NCT05380206
NCT05380206已完成不适用

Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty. Comparison With a Reference Non Arthritic Population

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle

研究概览

简要总结

The aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.

详细描述

Methods Five hundred and four navigated total knee arthroplasties will be analyzed. The following angles will be measured with a computer image free navigation system: medial femorotibial mechanical angle without stress and with maximum manual stress to reduce deformation, and medial distal femoral mechanical angle. The native medial distal femoral and medial proximal tibial angles will be calculated. The data will be analyzed as numerical and categorical data. These data will be then compared with those published in a non-arthritic population, considered as a control group.

The main criterion will be the percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle. The secondary criteria will be the percentages of subjects with normal medial femorotibial mechanical angle, normal native medial distal femoral angle and normal native medial proximal tibial angle. The influence of gender on primary and secondary criteria in the study group will be analyzed. The most frequent phenotypes in the study group will be identified.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle

时间窗: Files analysed retrospectively from January 01, 2011 to February 28, 2021 will be examined]

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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