Prosthetic Joint InfectionCOPINSNCT02801253
Cohort of Prosthetic Joint Infections
An observational study of Prosthetic Joint Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2015to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients managed in the investigators referral center of bone and joint infection, who meet protocol selection criteria will be included in the study. The investigators expect to recruit 400 patients.
Who may be able to join
- Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
- According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.
- Major Criteria:
- Two positive periprosthetic cultures with phenotypically identical organisms, OR
- A sinus tract communicating with the joint, OR
- Minor Criteria:
Show all 17Show fewer
- Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
- Elevated synovial fluid white blood cell (WBC)
- Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)
- The presence of pus in the joint without known cause
- Positive histological analysis of periprosthetic tissue
- A single positive culture
- Or a PJI which meets the following three criteria:
- Medical story suggesting prosthetic joint infection.
- The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.
- Germ identification in a single sample of fluid aspiration or tissue culture.
- Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml.
Who cannot join
- Patient who does not meet eligibility criteria.
- Patient lawfully deprived of his liberty.
- Patient not insured under social security scheme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, 75020
Younes KERROUMI, Doctorate, (+33)1 44 64 33 84, ykerroumi@hopital-dcss.org
Valérie ZELLER, Doctorate, (+33)1 44 64 17 80, vzeller@hopital-dcss.org
About this study
Official title: Prospective Cohort of Patients With Prosthetic Joint Infection
Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.
Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.
Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.
Read the detailed description
Large prospective cohort study in a French referral center for bone and joint infections.
Population
- all patients who consented to participate in the study with PJI treated with:
- debridement-synovectomy for acute infection
- with one-stage, two-stage exchange arthroplasty for chronic infection
- other procedures (complete removal of the prosthesis) and antibiotic therapy
- patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy
Outcome:
- Follow-up at least 2 years
- Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.
- Conditions
- Prosthetic Joint Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors
Measured: 2 years
Secondary outcomes (4)
Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty.
Measured: 1, 2, 4, 6 years
Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty
Measured: 6 years
Assessment of treatment failure rate in patients with hip and knee PJI 2 years after prolonged suppressive antibiotic therapy in non-operated patients.
Measured: 2 years
Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty.
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 posted15 Jun 2016 (estimated)
- Study start11 Sep 2015
- Primary completionSep 2025 (estimated)
- Study completionSep 2029 (estimated)
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.
- 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
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- VALERIE ZELLER, Doctorate, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801253
- Sponsor's protocol ID
- ID RCB: 2014-A01100-47
- Acronym
- COPINS
- Status last verified
- Mar 2022
- First submitted
- 27 May 2016
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Patients With Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT02801253
- Acronym / sponsor ID
- COPINS / ID RCB: 2014-A01100-47
- Conditions
- Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 11 Sep 2015 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.
Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.
Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.
Detailed description
Large prospective cohort study in a French referral center for bone and joint infections.
Population
- all patients who consented to participate in the study with PJI treated with:
- debridement-synovectomy for acute infection
- with one-stage, two-stage exchange arthroplasty for chronic infection
- other procedures (complete removal of the prosthesis) and antibiotic therapy
- patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy
Outcome:
- Follow-up at least 2 years
- Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients managed in the investigators referral center of bone and joint infection, who meet protocol selection criteria will be included in the study. The investigators expect to recruit 400 patients.
Key inclusion criteria (17 listed)
- Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
- According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.
- Two positive periprosthetic cultures with phenotypically identical organisms, OR
- A sinus tract communicating with the joint, OR
- Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
Key exclusion criteria (3 listed)
- Patient who does not meet eligibility criteria.
- Patient lawfully deprived of his liberty.
- Patient not insured under social security scheme.
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
Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors
Time frame: 2 years
4 secondary outcomes
Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty.
Time frame: 1, 2, 4, 6 years
Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty
Time frame: 6 years
Assessment of treatment failure rate in patients with hip and knee PJI 2 years after prolonged suppressive antibiotic therapy in non-operated patients.
Time frame: 2 years
Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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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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.
VALERIE ZELLER, Doctorate principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
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 Groupe Hospitalier Diaconesses Croix Saint-Simon 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 17 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YOUNES KERROUMI, Doctorate ((+33) 1 64 44 33 84, ykerroumi@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors (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 29 Mar 2022.