跳至主要内容
临床试验/NCT03848520
NCT03848520已完成不适用

Do People Run Following a TKA? A Cross-sectional Survey Study Addressed to Patients.

Brigitte Jolles, MD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月30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
20
试验地点
1
主要终点
Changes in number of runners following a TKA

研究概览

简要总结

The hypothesis of this study is that there are people running following a total knee arthroplasty (TKA).

The objective is (1) to determine if there are people that ran/run following their TKA and (2), in case (1) is true, to identify some general running parameters such as duration, frequency, perceived barriers for running.

Patients with a TKA and a score equal or higher than 9 on the UCLA activity scale at any time between 2 years prior to surgery and at present will be invited to participate in the trial by phone. All these patients will receive the study's information form and questionnaire by post with a pre-stamped envelope to return the documents.The survey was created and piloted internally for this study. There are 21 questions, most of them are "yes or no" and some others open questions to assess parameters such as duration of difficulties faced. The questionnaire is composed of three parts. The first part is interested in the preoperative activity (during the 2 years before surgery), the second part in the postoperative activity (during the 2 years after surgery) and the third part refers to the current practice. For each part, people are asked about specific practice parameters and modalities. Furthermore, we seek to determine whether there was/is a willingness to run following TKA, if patients receive any education/information about it and their personal attitudes towards running with a TKA. The anonymized data will be collected by the main author for subsequent analysis.

研究设计

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

入排标准

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

入选标准

  • •TKA and UCLA score = or > 9

排除标准

  • •Inability to read/write in french language
  • •Cognitive or neurological impairment

结局指标

主要结局

Changes in number of runners following a TKA

时间窗: From preoperatively to up to 20 years following TKA. From date of the preoperative assessment until the last clinical assessment available following TKA

Due to the limited number of patients availabe the analysis will be performed through a qualitative questionnaire. It has 21 questions, most of them are "yes or no" choice and some other open to assess parameters such as "number of runners", "frequency of running" (x/week), "duration of running" (min) and "patients' attitudes towards running" (adjectives reported) with a TKA. It is a patient based questionnaire to be send to each patient and returned by post.

次要结局

未报告次要终点

研究者

发起方
Brigitte Jolles, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brigitte Jolles, MD

Professor

University of Lausanne Hospitals

研究点 (1)

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