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临床试验/NCT03860025
NCT03860025Unknown不适用

"Patient Reported Outcome After Dislocation of a Primary THA"

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,000
试验地点
1
主要终点
QOL (Quality of life)

研究概览

简要总结

The aim is to compare QOL and hip specific outcome measures in patients with a single or recurrent episode(s) of THA dislocation and patients with a THA without any dislocation.

详细描述

Knowledge about the patient's own perception of both general health and more hip-related issues after experiencing a hip dislocation is lacking (19). Hip surgeons need this information in order to incorporate it with other objective aspects, when advising patients with their first hip dislocation. Due to the large study population, this study will provide solid information of what to expect after a hip dislocation and be the largest study ever conducted within this topic. Depending on the results, this study may change the path we choose to advise for our patients after single or recurrent dislocations.

A matched case-control study involving the share of THA patients with at least 1 episode of hip dislocation.

The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Given a 3-5% approximated incidence of dislocation, 1100-1800 cases will have been identified.

Patients are subdivided in groups depending on the number of dislocations and one group containing THA revisions. In order to be included, a time frame of at least 0,5 year since the last episode of dislocation or surgery must have passed.

A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • patients with one or more events of hip dislocation after a primary THA
  • controls with a primary THA without events of hip dislocation

排除标准

  • 未提供

结局指标

主要结局

QOL (Quality of life)

时间窗: 9 years

Measured by the EQ-5D questionnaire.

Hip function

时间窗: 9 years

Measured by the HOOS questionnaire.

次要结局

  • Activity(9 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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