Questionnaire and Radiography for Prosthesis Follow-up (Follow-up)
Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography
Ever-evolving prosthetic activity as described in a Swedish study that predicts 469 TKA per 10,000 inhabitants in 2130. Increased consultation of controls and post-arthroplasty follow-up is expected. There is a legal obligation to ensure long-term follow-up without official recommendation on follow-up procedures. The objective is to compare a consultation + Xray by the surgeon versus an Xray and a questionnaire completed by the patient who had a knee or hip replacement. This is to demonstrate the equivalence of both.
All patients who come back for an annual check of a prosthesis should complete this questionnaire and perform an X-ray of their prosthesis. The study lasts one year and includes all the patients with a previous knee or hip arthroplasty.
The result of the questionnaire and Xray will be compared to that of the consultation and Xray.
研究概览
地位
详细说明
An english study published an article showing that a follow up by questionnaire versus a consultation was also effective.
For this study, investigator is going to take back all the patients having to return to consultation in 2017. . Normally at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Thus investigator will be able to see the number of patients seen in consultation compared to the theoretical number The purpose of this study is to highlight the non-inferiority of the questionnaire compared to the consultation for screening for complications at 10 years.
If this proves to be the case, only complicating patients could be reviewed by calling them to the radio and their questionnaire.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Clermont-Ferrand、法国、63003
- CHU clermont-ferrand
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017. Normally at 3 months, 1 years, 3, 5, 10, 15 and 20 years post-operatively
Exclusion Criteria:
- Patients who have previous complications with their joint replacement
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group 1
a new long-term total articular prosthesis follow-up strategy by simple questionnaire and radiography (questionnaire and Xray for all patients)
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questionnaire and Xray for all patients
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patients seen in consultation follow-up or not (yes / no).
大体时间：at 3 months
|
Feasibility study of a new strategy of follow-up by questionnaire
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at 3 months
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Patients seen in consultation follow-up or not (yes / no).
大体时间：at 1year
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Feasibility study of a new strategy of follow-up by questionnaire
|
at 1year
|
|
Patients seen in consultation follow-up or not (yes / no).
大体时间：at 3 years
|
Feasibility study of a new strategy of follow-up by questionnaire
|
at 3 years
|
|
Patients seen in consultation follow-up or not (yes / no).
大体时间：at 5 years
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Feasibility study of a new strategy of follow-up by questionnaire
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at 5 years
|
|
Patients seen in consultation follow-up or not (yes / no).
大体时间：at 10 years
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Feasibility study of a new strategy of follow-up by questionnaire
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at 10 years
|
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Patients seen in consultation follow-up or not (yes / no).
大体时间：at 15 years
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Feasibility study of a new strategy of follow-up by questionnaire
|
at 15 years
|
|
Patients seen in consultation follow-up or not (yes / no).
大体时间：at 20 years
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Feasibility study of a new strategy of follow-up by questionnaire
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at 20 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
economic impact (Number of working day)
大体时间：at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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Number of working day in days
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at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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economic impact (Number of consultations)
大体时间：at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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Number of consultations with the surgeon,
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at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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economic impact (Number of radiography)
大体时间：at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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Number of radiography realized by the patient
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at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
|
|
economic impact (Cost phone call)
大体时间：at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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According to the number of realized phone call
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at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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Evaluation of the feasibility of the questionnaire for detection of certain complications
大体时间：at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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Evaluation of the feasibility of the questionnaire method
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at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
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合作者和调查者
调查人员
- 首席研究员：Roger ERIVAN、University Hospital, Clermont-Ferrand
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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