Knee ArthritisNCT05521555
Return to Work After Total Knee Arthroplasty in Young Patients
An observational study of Knee Arthritis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study takes its base in the augmenting number of primary total knee arthroplasty in the world whom quality and survey had permit to widen their indications to younger patients who are in the age of professional activity. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2022to 20 Sep 2022
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who underwent a total knee arthroplasty, under 55 at the time of surgery, with or without professional activity at the time of surgery
Who may be able to join
- first intention total knee arthroplasty
- Age at the time of surgery under 55
Who cannot join
- Not in capacity of completing a questionnaire
- revision of total knee arthroplasty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy, Hopital central
Nancy, Meurthe Et Moselle, 54000
Didier MAINARD, PHD, 03 83 85 17 82, didier.mainard@univ-lorraine.fr
About this study
Official title: Return to Work After Total Knee Arthroplasty in Patients Under 55, a Retrospective Study in an University Hospital
This study takes its base in the augmenting number of primary total knee arthroplasty in the world whom quality and survey had permit to widen their indications to younger patients who are in the age of professional activity.
This work will focus on young patients under 55 who had had primary total knee arthroplasty, retrospectively, over the past 10 years, to determine the factors influencing early or late return to work, depending of socio economics factors.
This will optimize the information for the patient, and prepare him if necessary for a long work stop, and possibly obtain a better satisfaction for him.
Read the detailed description
The primary aim of this study is to determine the rate of young patients returning to work after a primary total knee arthroplasty and the mean delay, and to compare it to other studies.
The mean delay of return to work in the literature is between 8 to 12 weeks, with up to 98% of patients returning to work.
The investigators will next determine which category of patients could have a late return to work superior to 6 months, and also if the surgery could give back a professional activity to patients who were in a long work stoppage.
- Conditions
- Knee Arthritis
- Being tested
- Total knee arthroplasty
- Keywords
- total knee arthroplasty, return to work, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
First intention total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| total knee arthroplasty under 55 | Patient who had total knee arthroplasty before 55 between January 2010 and December 2019 Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work in weeks
Duration between surgery and return to work
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start20 Jul 2022
- Primary completion10 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier MAINARD, Central Hospital, Nancy, France
- Investigators
- Didier MAINARD, PHD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521555
- Sponsor's protocol ID
- 2022-A00947-36
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work After Total Knee Arthroplasty in Patients Under 55, a Retrospective Study in an University Hospital
- ClinicalTrials.gov ID
- NCT05521555
- Acronym / sponsor ID
- 2022-A00947-36
- Conditions
- Knee Arthritis
- Keywords
- total knee arthroplasty, return to work, arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 30 Aug 2022 (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.
This study takes its base in the augmenting number of primary total knee arthroplasty in the world whom quality and survey had permit to widen their indications to younger patients who are in the age of professional activity.
This work will focus on young patients under 55 who had had primary total knee arthroplasty, retrospectively, over the past 10 years, to determine the factors influencing early or late return to work, depending of socio economics factors.
This will optimize the information for the patient, and prepare him if necessary for a long work stop, and possibly obtain a better satisfaction for him.
Detailed description
The primary aim of this study is to determine the rate of young patients returning to work after a primary total knee arthroplasty and the mean delay, and to compare it to other studies.
The mean delay of return to work in the literature is between 8 to 12 weeks, with up to 98% of patients returning to work.
The investigators will next determine which category of patients could have a late return to work superior to 6 months, and also if the surgery could give back a professional activity to patients who were in a long work stoppage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total knee arthroplasty under 55 | – | Procedure: Total knee arthroplastyPatient who had total knee arthroplasty before 55 between January 2010 and December 2019 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who underwent a total knee arthroplasty, under 55 at the time of surgery, with or without professional activity at the time of surgery
Key inclusion criteria (2 listed)
- first intention total knee arthroplasty
- Age at the time of surgery under 55
Key exclusion criteria (2 listed)
- Not in capacity of completing a questionnaire
- revision of total knee arthroplasty
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 |
|---|---|---|
| Total knee arthroplastyFirst intention total knee arthroplasty | Procedure or surgery | total knee arthroplasty under 55 |
Primary outcome
Return to work in weeks
Time frame: 2 years
Duration between surgery and return to work
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- return to work after total knee or hip arthroplastyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Didier MAINARD, PHD principal investigator
CHRU Nancy
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 Knee Arthritis, run by Central Hospital, Nancy, France 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Mainard, PHD (03 83 85 17 82, didier.mainard@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work in weeks (time frame: 2 years). 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 30 Aug 2022.