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

6. april 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

656

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Clermont-Ferrand, Frankrike, 63003
        • CHU clermont-ferrand

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Clermont-Ferrand

Etterforskere

  • Hovedetterforsker: Roger ERIVAN, University Hospital, Clermont-Ferrand

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. oktober 2018

Primær fullføring (Faktiske)

30. oktober 2019

Studiet fullført (Faktiske)

30. oktober 2019

Datoer for studieregistrering

Først innsendt

19. oktober 2018

Først innsendt som oppfylte QC-kriteriene

16. november 2018

Først lagt ut (Faktiske)

19. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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