Bone and Joint InfectionNCT04722926
Lyon PJI Retrospective Cohort Study
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- PJI
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2022to 1 Mar 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients having had a PJI between 2018 and 2020 managed at the CRIOAc Lyon
Who may be able to join
- patients having had a PJI between 2018 and 2020
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA
About this study
Official title: Lyon Prosthetic Joint Infection Retrospective Cohort Study
Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs.
This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.
- Conditions
- Bone and Joint Infection
- Being tested
- PJI
- Keywords
- prosthesis joint infection, relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PJIOther
patients having had a PJI managed at the CRIOAc Lyon, with or without relapse
| Study group | Role | What they receive |
|---|---|---|
| PJI | Patients having had a PJI Receives: Other: PJI |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of PJI
proportion of PJI among all BJI
Measured: between 2018 and 2020
Description of PJI
acute/chronic
Measured: between 2018 and 2020
Description of type of prosthesis PJI
number of prosthesis
Measured: between 2018 and 2020
Description of patients having had a PJI
type of patients: age
Measured: between 2018 and 2020
Description of comorbidities of patients having had a PJI
type of comorbidities..
Measured: between 2018 and 2020
rate of bacteria
epidemiologic description of PJI
Measured: between 2018 and 2020
description of antibiotic used
type of antibiotic : name
Measured: between 2018 and 2020
description of antibiotic treatment
duration of antibiotic treatment
Measured: between 2018 and 2020
description of surgical treatment
type of surgery: 1-step exchange, 2- step exchange, DAIR
Measured: between 2018 and 2020
Secondary outcomes (2)
rate of failure
proportion of patients having a failure
Measured: between 2018 and 2020
description of the failure
type of failure : persistence or surinfection and management of failure
Measured: between 2018 and 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start10 Jan 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722926
- Sponsor's protocol ID
- 268
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyon Prosthetic Joint Infection Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04722926
- Acronym / sponsor ID
- 268
- Conditions
- Bone and Joint Infection
- Keywords
- prosthesis joint infection, relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 25 Jan 2021 (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.
Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs.
This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PJI | – | Other: PJIPatients having had a PJI |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients having had a PJI between 2018 and 2020 managed at the CRIOAc Lyon
Key inclusion criteria (1 listed)
- patients having had a PJI between 2018 and 2020
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PJIpatients having had a PJI managed at the CRIOAc Lyon, with or without relapse | Other | PJI |
Primary outcome
rate of PJI
Time frame: between 2018 and 2020
proportion of PJI among all BJI
Description of PJI
Time frame: between 2018 and 2020
acute/chronic
Description of type of prosthesis PJI
Time frame: between 2018 and 2020
number of prosthesis
Description of patients having had a PJI
Time frame: between 2018 and 2020
type of patients: age
Description of comorbidities of patients having had a PJI
Time frame: between 2018 and 2020
type of comorbidities..
rate of bacteria
Time frame: between 2018 and 2020
epidemiologic description of PJI
description of antibiotic used
Time frame: between 2018 and 2020
type of antibiotic : name
description of antibiotic treatment
Time frame: between 2018 and 2020
duration of antibiotic treatment
description of surgical treatment
Time frame: between 2018 and 2020
type of surgery: 1-step exchange, 2- step exchange, DAIR
2 secondary outcomes
rate of failure
Time frame: between 2018 and 2020
description of the failure
Time frame: between 2018 and 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Bone and Joint Infection, run by Hospices Civils de Lyon 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: status not confirmed, as of the sponsor's last update on 20 Jan 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 Eugenie Mabrut, CRA (. 04 26 73 29 38, eugenie.mabrut@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of PJI (time frame: between 2018 and 2020). The study lists 9 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 20 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.