Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography
Questionnaire and Radiography for Prosthesis Follow-up
Lead sponsor: University Hospital, Clermont-Ferrand
|Source||University Hospital, Clermont-Ferrand|
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.
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.
|Start Date||October 15, 2018|
|Completion Date||October 30, 2019|
|Primary Completion Date||October 30, 2019|
Intervention type: Procedure
Intervention name: questionnaire and Xray for all patients
Description: questionnaire and Xray for all patients
Arm group label: Group 1
Sampling method: Non-Probability Sample
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
- 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
- Patients who have previous complications with their joint replacement
Minimum age: 18 Years
Maximum age: N/A
Healthy volunteers: No
Responsible party type: Sponsor
|Has Expanded Access||No|
Arm group label: Group 1
Description: a new long-term total articular prosthesis follow-up strategy by simple questionnaire and radiography (questionnaire and Xray for all patients)
|Study Design Info||
Observational model: Cohort
Time perspective: Prospective