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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63003
- CHU clermont-ferrand
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patients seen in consultation follow-up or not (yes / no).
기간: 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
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Patients seen in consultation follow-up or not (yes / no).
기간: at 1year
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Feasibility study of a new strategy of follow-up by questionnaire
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at 1year
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Patients seen in consultation follow-up or not (yes / no).
기간: at 3 years
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Feasibility study of a new strategy of follow-up by questionnaire
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at 3 years
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Patients seen in consultation follow-up or not (yes / no).
기간: 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
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Patients seen in consultation follow-up or not (yes / no).
기간: 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).
기간: at 15 years
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Feasibility study of a new strategy of follow-up by questionnaire
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at 15 years
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Patients seen in consultation follow-up or not (yes / no).
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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economic impact (Number of working day)
기간: 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)
기간: 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)
기간: 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.
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economic impact (Cost phone call)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Roger ERIVAN, University Hospital, Clermont-Ferrand
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
questionnaire and Xray for all patients에 대한 임상 시험
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Ankara Yildirim Beyazıt University모병