Prosthetic Joint InfectionNCT03612076
Cost Of Failure Following Reimplantation After a 2-Stage Exchange Strategy For Hip Or Knee Prosthetic Joint Infection
An observational study of Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
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
- Prosthetic Joint Infection
- What is being tested?
- Global cost of management of PJI
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2016to 1 Jul 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.
Who may be able to join
- patients with prosthetic joint infection having had a 2-step exchange and managed at the CRIOAc from at least the reimplantation (between 2013 and 2015)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost of Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
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 of this study is to determine the global cost of management of prosthetic joint infection.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Global cost of management of PJI
- Keywords
- prosthetic joint infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global cost of management of PJIOther
estimation of the global cost to manage PJI with 2-step exchange over 3 years
| Study group | Role | What they receive |
|---|---|---|
| Global cost of management of PJI | Not described Receives: Other: Global cost of management of PJI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cost of management of PJI
The following data are collected : duration of hospitalization at the Croix Rousse hospital (surgery unit, department of infectiology, other…) and in post-acute care structures, bacteriology, surgeries, medical treatments… and all acts realized throughout the management of the PJI.
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 posted2 Aug 2018
- Study start1 Dec 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Heraeus Medical GmbH
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, Md,PhD, Principal investigator, Hospices Civils de Lyon - Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612076
- Sponsor's protocol ID
- 17-089
- Status last verified
- Dec 2020
- First submitted
- 27 Jul 2018
- Last updated
- 16 Dec 2020
- 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 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost of Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03612076
- Acronym / sponsor ID
- 17-089
- Conditions
- Prosthetic Joint Infection
- Keywords
- prosthetic joint infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Heraeus Medical GmbH
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 2 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 of this study is to determine the global cost of management of prosthetic joint infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Global cost of management of PJI | – | Other: Global cost of management of PJI |
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.
Key inclusion criteria (1 listed)
- patients with prosthetic joint infection having had a 2-step exchange and managed at the CRIOAc from at least 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 |
|---|---|---|
| Global cost of management of PJIestimation of the global cost to manage PJI with 2-step exchange over 3 years | Other | Global cost of management of PJI |
Primary outcome
Global cost of management of PJI
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
The following data are collected : duration of hospitalization at the Croix Rousse hospital (surgery unit, department of infectiology, other…) and in post-acute care structures, bacteriology, surgeries, medical treatments… and all acts realized throughout the management of the PJI.
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 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Prosthetic Joint Infection
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
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oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
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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
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 Prosthetic 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: finished, as of the sponsor's last update on 16 Dec 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?
Global cost of management of PJI (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 16 Dec 2020.