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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Clermont-Ferrand、フランス、63003
- CHU Clermont-Ferrand
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patients seen in consultation follow-up or not (yes / no).
時間枠：at 3 months
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Feasibility study of a new strategy of follow-up by questionnaire
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at 3 months
|
|
Patients seen in consultation follow-up or not (yes / no).
時間枠：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).
時間枠：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).
時間枠：at 5 years
|
Feasibility study of a new strategy of follow-up by questionnaire
|
at 5 years
|
|
Patients seen in consultation follow-up or not (yes / no).
時間枠：at 10 years
|
Feasibility study of a new strategy of follow-up by questionnaire
|
at 10 years
|
|
Patients seen in consultation follow-up or not (yes / no).
時間枠：at 15 years
|
Feasibility study of a new strategy of follow-up by questionnaire
|
at 15 years
|
|
Patients seen in consultation follow-up or not (yes / no).
時間枠：at 20 years
|
Feasibility study of a new strategy of follow-up by questionnaire
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at 20 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
economic impact (Number of working day)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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.
|
協力者と研究者
捜査官
- 主任研究者：Roger ERIVAN、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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