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Questionnaire and Radiography for Prosthesis Follow-up

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03745976
Acronym
Follow-up
Enrollment
656
Registered
2018-11-19
Start date
2018-10-15
Completion date
2019-10-30
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Annual Follow-up, Hip and Knee Arthroplasties, Without Known Complication

Keywords

follow-up, total knee arthroplasty, total hip arthroplasty

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.

Interventions

PROCEDUREquestionnaire and Xray for all patients

questionnaire and Xray for all patients

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients seen in consultation follow-up or not (yes / no).at 3 monthsFeasibility study of a new strategy of follow-up by questionnaire

Secondary

MeasureTime frameDescription
economic impact (Number of working day)at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.Number of working day in days
economic impact (Number of consultations)at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.Number of consultations with the surgeon,
economic impact (Number of radiography)at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.Number of radiography realized by the patient
economic impact (Cost phone call)at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.According to the number of realized phone call
Evaluation of the feasibility of the questionnaire for detection of certain complicationsat 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.Evaluation of the feasibility of the questionnaire method

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026