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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63003
- CHU Clermont-Ferrand
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patients seen in consultation follow-up or not (yes / no).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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economic impact (Number of working day)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Roger ERIVAN, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CHU-412
- 2018-A01022-53 (Otro identificador: 2018-A01022-53)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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