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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Clermont-Ferrand, Frankrijk, 63003
- CHU clermont-ferrand
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Patients seen in consultation follow-up or not (yes / no).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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
|
|
Patients seen in consultation follow-up or not (yes / no).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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economic impact (Number of working day)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Roger ERIVAN, University Hospital, Clermont-Ferrand
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CHU-412
- 2018-A01022-53 (Andere identificatie: 2018-A01022-53)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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