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Completed

NCT Number: NCT03745976

Questionnaire and Radiography for Prosthesis Follow-up

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.

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Key information

Conditions

Hip and Knee Arthroplasties Annual Follow-up Without Known Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaire and Xray for all patients

Procedure

questionnaire and Xray for all patients

Primary outcomes

  1. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 3 months

    Feasibility study of a new strategy of follow-up by questionnaire

  2. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 1year

    Feasibility study of a new strategy of follow-up by questionnaire

  3. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 3 years

    Feasibility study of a new strategy of follow-up by questionnaire

  4. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 5 years

    Feasibility study of a new strategy of follow-up by questionnaire

  5. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 10 years

    Feasibility study of a new strategy of follow-up by questionnaire

  6. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 15 years

    Feasibility study of a new strategy of follow-up by questionnaire

  7. Patients seen in consultation follow-up or not (yes / no).

    Time frame: at 20 years

    Feasibility study of a new strategy of follow-up by questionnaire

Secondary outcomes

  1. economic impact (Number of working day)

    Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.

    Number of working day in days

  2. economic impact (Number of consultations)

    Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.

    Number of consultations with the surgeon,

  3. economic impact (Number of radiography)

    Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.

    Number of radiography realized by the patient

  4. economic impact (Cost phone call)

    Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.

    According to the number of realized phone call

  5. Evaluation of the feasibility of the questionnaire for detection of certain complications

    Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.

    Evaluation of the feasibility of the questionnaire method

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: Follow-up

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2018
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.