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Questionnaire and Radiography for Prosthesis Follow-up (Follow-up)

6. april 2020 opdateret af: University Hospital, Clermont-Ferrand

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

656

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Clermont-Ferrand, Frankrig, 63003
        • Chu Clermont-Ferrand

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group 1
a new long-term total articular prosthesis follow-up strategy by simple questionnaire and radiography (questionnaire and Xray for all patients)
Procedure: questionnaire and Xray for all patients
questionnaire and Xray for all patients

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients seen in consultation follow-up or not (yes / no).
Tidsramme: at 3 months
Feasibility study of a new strategy of follow-up by questionnaire
at 3 months
Patients seen in consultation follow-up or not (yes / no).
Tidsramme: at 1year
Feasibility study of a new strategy of follow-up by questionnaire
at 1year
Patients seen in consultation follow-up or not (yes / no).
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: at 20 years
Feasibility study of a new strategy of follow-up by questionnaire
at 20 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
economic impact (Number of working day)
Tidsramme: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Number of working day in days
at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of consultations)
Tidsramme: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Number of consultations with the surgeon,
at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of radiography)
Tidsramme: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Number of radiography realized by the patient
at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Cost phone call)
Tidsramme: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
According to the number of realized phone call
at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Evaluation of the feasibility of the questionnaire for detection of certain complications
Tidsramme: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Evaluation of the feasibility of the questionnaire method
at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Efterforskere

  • Ledende efterforsker: Roger ERIVAN, University Hospital, Clermont-Ferrand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2018

Primær færdiggørelse (Faktiske)

30. oktober 2019

Studieafslutning (Faktiske)

30. oktober 2019

Datoer for studieregistrering

Først indsendt

19. oktober 2018

Først indsendt, der opfyldte QC-kriterier

16. november 2018

Først opslået (Faktiske)

19. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CHU-412
  • 2018-A01022-53 (Anden identifikator: 2018-A01022-53)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med questionnaire and Xray for all patients

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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