- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03745976
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Clermont-Ferrand, Frankrike, 63003
- CHU clermont-ferrand
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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)
|
questionnaire and Xray for all patients
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patients seen in consultation follow-up or not (yes / no).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: 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).
Tidsram: at 20 years
|
Feasibility study of a new strategy of follow-up by questionnaire
|
at 20 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
economic impact (Number of working day)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Roger ERIVAN, University Hospital, Clermont-Ferrand
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CHU-412
- 2018-A01022-53 (Annan identifierare: 2018-A01022-53)
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