NCT03745976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
656

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

October 19, 2018

Last Update Submit

April 6, 2020

Conditions

Hip and Knee ArthroplastiesWithout Known ComplicationAnnual Follow-up

Keywords

follow-uptotal knee arthroplastytotal hip arthroplasty

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (5)

  • economic impact (Number of working day)

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

  • economic impact (Number of consultations)

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

  • economic impact (Number of radiography)

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

  • economic impact (Cost 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

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

Study Arms (1)

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

Interventions

questionnaire and Xray for all patientsPROCEDURE

questionnaire and Xray for all patients

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have previous complications with their joint replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Surveys and QuestionnairesX-Rays

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Roger ERIVAN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2018

First Posted

November 19, 2018

Study Start

October 15, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

FR(1)