Hip and Knee ArthroplastiesFollow-upNCT03745976
Questionnaire and Radiography for Prosthesis Follow-up
An observational study of Hip and Knee Arthroplasties and Without Known Complication, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip and Knee Arthroplasties, Without Known Complication, Annual Follow-up
- What is being tested?
- questionnaire and Xray for all patients
- Type of treatment
- Surgery or procedure
- How many people
- 656 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2018to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017
Who may be able to join
- 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
Who cannot join
- Patients who have previous complications with their joint replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- questionnaire and Xray for all patients
- Keywords
- follow-up, total knee arthroplasty, total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire and Xray for all patientsProcedure or surgery
questionnaire and Xray for all patients
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | a new long-term total articular prosthesis follow-up strategy by simple questionnaire and radiography (questionnaire and Xray for all patients) Receives: Procedure: questionnaire and Xray for all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 3 months
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 1year
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 3 years
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 5 years
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 10 years
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 15 years
Patients seen in consultation follow-up or not (yes / no).
Feasibility study of a new strategy of follow-up by questionnaire
Measured: at 20 years
Secondary outcomes (5)
economic impact (Number of working day)
Number of working day in days
Measured: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of consultations)
Number of consultations with the surgeon,
Measured: 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
Measured: 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
Measured: 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
Measured: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start15 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip and Knee ArthroplastiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger ERIVAN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745976
- Sponsor's protocol ID
- CHU-412
- Other IDs
- 2018-A01022-53
- Acronym
- Follow-up
- Status last verified
- Apr 2020
- First submitted
- 19 Oct 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography
- ClinicalTrials.gov ID
- NCT03745976
- Acronym / sponsor ID
- Follow-up / CHU-412
- Keywords
- follow-up, total knee arthroplasty, total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 656 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: questionnaire and Xray for all patientsa new long-term total articular prosthesis follow-up strategy by simple questionnaire and radiography (questionnaire and Xray for all patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have previous complications with their joint replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire and Xray for all patientsquestionnaire and Xray for all patients | Procedure or surgery | Group 1 |
Primary outcome
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
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
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
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
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
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
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
5 secondary outcomes
economic impact (Number of working day)
Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of consultations)
Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Number of radiography)
Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
economic impact (Cost phone call)
Time frame: 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
Time frame: at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger ERIVAN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip and Knee Arthroplasties and Without Known Complication, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients seen in consultation follow-up or not (yes / no). (time frame: at 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.