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Questionnaire and Radiography for Prosthesis Follow-up (Follow-up)

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ClinicalTrials.gov Identifier: NCT03745976
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Hip and Knee Arthroplasties Without Known Complication Annual Follow-up 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.


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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745976


Contacts
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Contact: Lise LACLAUTRE 0473754963 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Roger ERIVAN         
Sub-Investigator: Thibault CHAPUT         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Roger ERIVAN University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03745976     History of Changes
Other Study ID Numbers: CHU-412
2018-A01022-53 ( Other Identifier: 2018-A01022-53 )
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
follow-up
total knee arthroplasty
total hip arthroplasty