Questionnaire and Radiography for Prosthesis Follow-up

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography

Conditions
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Hip and Knee Arthroplasties, Without Known Complication, Annual Follow-up

Intervention / Treatment
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* Procedure: questionnaire and Xray for all patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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<br>* questionnaire and Xray for all patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 3 months | 
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 1year | 
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 3 years | 
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 5 years | 
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 10 years | 
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 15 years | 
| Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| economic impact (Number of working day) | Number of working day in days | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | 
| economic impact (Number of consultations) | Number of consultations with the surgeon, | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | 
| economic impact (Number of radiography) | 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) | 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 | Evaluation of the feasibility of the questionnaire method | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow-up, total knee arthroplasty, total hip arthroplasty