Exchange of Prosthetic JointNCT03473392
One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections
An observational study of Exchange of Prosthetic Joint and Prosthetic Joint Infection, run by Hospices Civils de Lyon.
Trial summary
The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exchange of Prosthetic Joint, Prosthetic Joint Infection, One-step Exchange
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having had puncture which allowed to identify bacteria responsible for the IPA and having had a pre-treatment for a few days against those bacteria before a one-step exchange of prosthetic joint
Who may be able to join
- patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital
- > 18 years old
Who cannot join
- -
About this study
The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,..
A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed.
The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.
- Keywords
- pre-treatment, antibiotherapy, prosthetic joint infection, treatment failure
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial epidemiology
This outcome will describe the bacterial epidemiology identified with a punction, the antibiotherapy used for pre-treatment, the characteristics of patients and the PJI.
Measured: at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes (1)
Treatment failure
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
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 posted22 Mar 2018
- Study startApr 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exchange of Prosthetic JointStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan FERRY, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473392
- Sponsor's protocol ID
- 69HCL18_0237
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections
- ClinicalTrials.gov ID
- NCT03473392
- Acronym / sponsor ID
- 69HCL18_0237
- Keywords
- pre-treatment, antibiotherapy, prosthetic joint infection, treatment failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 22 Mar 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.
The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,..
A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed.
The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having had puncture which allowed to identify bacteria responsible for the IPA and having had a pre-treatment for a few days against those bacteria before a one-step exchange of prosthetic joint
Key inclusion criteria (2 listed)
- patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital
- > 18 years old
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.
Primary outcome
bacterial epidemiology
Time frame: at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
This outcome will describe the bacterial epidemiology identified with a punction, the antibiotherapy used for pre-treatment, the characteristics of patients and the PJI.
1 secondary outcome
Treatment failure
Time frame: 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 22 Mar 2018.
Related trials for Exchange of Prosthetic Joint
Active, not recruitingPhase 2
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee
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 principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Exchange of Prosthetic Joint and Prosthetic Joint Infection, 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 2 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 22 Mar 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?
bacterial epidemiology (time frame: 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 22 Mar 2018.