Bone and Joint InfectionNCT03627000
Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
An observational study of Bone and Joint Infection and Bacterial Infections, run by Hospices Civils de Lyon.
Trial summary
This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done. A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone and Joint Infection, Bacterial Infections, EPIDEMIOLOGY
- What is being tested?
- failure after reimplantation
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Apr 2018
- 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 100 years
- All sexes
- Adult, Older adult
Study population: patients with prosthetic joint infection having had a 2-step exchange managed at the Croix Rousse Hospital from the reimplantation, between 2013 and 2015.
Who may be able to join
- patients with prosthetic joint infection having had a 2-step exchange at least from the reimplantation, between 2013 and 2015.
Who cannot join
- -
About this study
This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done.
A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation.
The aim is to determine the microbiological epidemiology in patients experiencing failure following reimplantation to establish, based on the drug susceptibilities, which cement could be the most active.
- Conditions
- Bone and Joint Infection, Bacterial Infections, EPIDEMIOLOGY
- Being tested
- failure after reimplantation
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
failure after reimplantationOther
description of cinical and microbiological failure
| Study group | Role | What they receive |
|---|---|---|
| failure after reimplantation | description of the failure at the reimplantation Receives: Other: failure after reimplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of treatment failure
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes (2)
rate of bacteria involved in microbiological failure
description of microbiological failure : bacteria responsible of microbiological failure
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
rate of clinical failure
description of clinical failure
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Oct 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Tristan FERRY, Md,PhD, Principal investigator, Hospices Civils de Lyon Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627000
- Sponsor's protocol ID
- 17-089-2
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 13 Aug 2018
- 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 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03627000
- Acronym / sponsor ID
- 17-089-2
- Conditions
- Bone and Joint Infection, Bacterial Infections, EPIDEMIOLOGY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 13 Aug 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.
This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done.
A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation.
The aim is to determine the microbiological epidemiology in patients experiencing failure following reimplantation to establish, based on the drug susceptibilities, which cement could be the most active.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| failure after reimplantation | – | Other: failure after reimplantationdescription of the failure at the reimplantation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with prosthetic joint infection having had a 2-step exchange managed at the Croix Rousse Hospital from the reimplantation, between 2013 and 2015.
Key inclusion criteria (1 listed)
- patients with prosthetic joint infection having had a 2-step exchange at least from the reimplantation, between 2013 and 2015.
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 |
|---|---|---|
| failure after reimplantationdescription of cinical and microbiological failure | Other | failure after reimplantation |
Primary outcome
rate of treatment failure
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
2 secondary outcomes
rate of bacteria involved in microbiological failure
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
rate of clinical failure
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
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 13 Aug 2018.
- 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.
Tristan FERRY, Md,PhD principal investigator
Hospices Civils de Lyon Hôpital de la Croix-Rousse
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Joint Infection and Bacterial Infections, run by Hospices Civils de Lyon.
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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
rate of treatment failure (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)). 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 13 Aug 2018.