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临床试验/NCT01495507
NCT01495507Unknown不适用

Cross-cultural Adaptation and Validation of the German Version of the Kujala Score in Patients With Patellofemoral Instability - a Prospective Multi-centric Study

Medical University Innsbruck1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Kujala Score

研究概览

简要总结

The field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used in many studies investigating patellofemoral disorders - also in german speaking patient groups. Unfortunately, we are not aware of a validated german version of the Kujala score. Other relevant knee outcome scores were already successfully translated into german language and validated by previous investigators.

So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala score for use in German-speaking individuals with patellofemoral instability. It is hypothesized that the german version of the Kujala score shows:

  • High divergent construct validity as determined by significant differences between patients and controls (hypothesis 1)
  • High convergent construct validity as determined by significant correlations with other relevant scoring systems (hypothesis 2)
  • High reliability (hypothesis 3)
  • High responsiveness (hypothesis 4)

研究设计

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

入排标准

年龄范围
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • german speaking
  • MPFL-reconstruction planed

排除标准

  • 未提供

结局指标

主要结局

Kujala Score

时间窗: 1 year

KOOS (Knee Injury and Osteoarthritis Outcome Score)

时间窗: 1 year

Marx Activity Scale

时间窗: 1 year

SF-12 (Short - Form 12)

时间窗: 1 year

VAS pain

时间窗: 1 year

Lysholm Score

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Liebensteiner

MD, PhD

Medical University Innsbruck

研究点 (1)

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