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.

Study Overview

• Status: Completed
• Conditions: Hip and Knee Arthroplasties; Without Known Complication; Annual Follow-up
• Intervention / Treatment: Procedure: questionnaire and Xray for all patients

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.

• Study Type: Observational
• Enrollment (Actual): 656

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 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; questionnaire and Xray for all patients

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Roger ERIVAN, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: total hip arthroplasty; follow-up; total knee arthroplasty
• Other Study ID Numbers: CHU-412; 2018-A01022-53 (Other Identifier: 2018-A01022-53)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No