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

Questionnaire and Radiography for Prosthesis Follow-up

Sponsors

Lead sponsor: University Hospital, Clermont-Ferrand

Source University Hospital, Clermont-Ferrand
Brief Summary

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

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.

Overall Status Completed
Start Date October 15, 2018
Completion Date October 30, 2019
Primary Completion Date October 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Patients seen in consultation follow-up or not (yes / no). at 3 months
Patients seen in consultation follow-up or not (yes / no). at 1year
Patients seen in consultation follow-up or not (yes / no). at 3 years
Patients seen in consultation follow-up or not (yes / no). at 5 years
Patients seen in consultation follow-up or not (yes / no). at 10 years
Patients seen in consultation follow-up or not (yes / no). at 15 years
Patients seen in consultation follow-up or not (yes / no). at 20 years
Secondary Outcome
Measure Time Frame
economic impact (Number of working day) at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of consultations) at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of radiography) at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Cost 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 at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Enrollment 656
Condition
Intervention

Intervention type: Procedure

Intervention name: questionnaire and Xray for all patients

Description: questionnaire and Xray for all patients

Arm group label: Group 1

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Roger ERIVAN Principal Investigator University Hospital, Clermont-Ferrand
Location
facility
Chu Clermont-Ferrand
Location Countries

France

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Arm Group

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)

Acronym Follow-up
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov