Clinical trial NCT03745976: Questionnaire and Radiography for Prosthesis Follow-up
Official title: Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip and Knee Arthroplasties
Without Known Complication
Annual Follow-up
Keywords: follow-up
total knee arthroplasty
total hip arthroplasty
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017

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.

Eligibility 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

Primary outcomes:
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 3 months
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 1year
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 3 years
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 5 years
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 10 years
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 15 years
measure: Patients seen in consultation follow-up or not (yes / no).
timeFrame: at 20 years
Secondary outcomes:
measure: economic impact (Number of working day)
timeFrame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
measure: economic impact (Number of consultations)
timeFrame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
measure: economic impact (Number of radiography)
timeFrame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
measure: economic impact (Cost phone call)
timeFrame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
measure: Evaluation of the feasibility of the questionnaire for detection of certain complications
timeFrame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Roger ERIVAN
role: PRINCIPAL_INVESTIGATOR
References: