Joint InfectionNCT06267287
Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period
An observational study of Joint Infection and Periprosthetic Left Knee Joint Infection, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
Trial summary
Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Joint Infection, Periprosthetic Left Knee Joint Infection
- What is being tested?
- Microbiological examination of the patient's biological material and determination of antibiotic resistance
- How many people
- 342 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2018to 31 Dec 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The sample included cases of deep and superficial infection after arthroplasty of the knee, hip, shoulder and wrist joints, regardless of the location of the primary operation. Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment).
Who may be able to join
- Clinically confirmed periprosthetic infection
Who cannot join
- No signs of periprosthetic infection
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Center for Traumatology, Orthopedics and Endoprosthetics
Cheboksary, Chuvashskaya Respublika, 429500
About this study
Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods.
Read the detailed description
A continuous comparative retrospective study of cases of PJI of the joints of the extremities with positive microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods was carried out on the data basis from the medical information system (MIS) of the Federal Center for Traumatology, Orthopedics and Arthroplasty of Ministry of Health of Russia (Cheboksary, Russia), hereinafter referred to as the Center.
Verification of the diagnosis of deep PJI was carried out according to the diagnostic criteria of the Society for Musculoskeletal Infections.
The sample included cases of deep and superficial infection after arthroplasty of the knee, hip, shoulder and wrist joints, regardless of the location of the primary operation. Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment).
The infection was classified as polymicrobial or monomicrobial. The role of the leading pathogen was determined in the structure of monomicrobial infection. Polymicrobial infection is represented by cases of simultaneous isolation of two or more pathogens in one patient. The antibiotic resistance profile included all isolated pathogens of mono- and polymicrobial PJI.
At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination.
The aspirate from the joint was placed into FA plus, FN plus bottles of the Bact/Alert 3D analyzer (Bio Merieux, France). If the sample volume was insufficient (less than 1 ml), it was inoculated into a vial with Schedler's broth and, when turbid, subcultured onto solid media.
The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. After ultrasonication, 0.5 ml of the resulting liquid was applied to solid media.
Homogenized tissue samples were placed in broth with thioglycollate medium. The cultures were incubated at 37°C for up to 14 days, subcultured on solid nutrient media: on the 1st day - on Columbia, Chocolate and Schedler agars; on the 5th day - on Chocolate and Schedler agar and on the 10th day - only on Schedler agar. For aerobic, anaerobic and capnophilic microorganisms, incubation conditions were created using gas-generating packages.
Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer (Vitec2 compact; Bio Merieux, France) and a semi-automatic analyzer (Multiscan FC; Thermo Fisher, USA) using kits (Erba Lachema, Czech Republic), test systems ("Diagnostic systems", Russia).
Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2018 (studies in 2018-2019), EUCAST 2021 (studies in 2021-2022).
- Being tested
- Microbiological examination of the patient's biological material and determination of antibiotic resistance
- Keywords
- periprosthetic infection; antibiotic resistance; Staphylococcus epidermidis; pathogens of periprosthetic infection; COVID-19; empirical antibiotic therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological examination of the patient's biological material and determination of antibiotic resistanceDiagnostic test
Also called Identification of the infectious agent and determination of antibiotic resistance
Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment). At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination. The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer and a semi-automatic analyzer using kits, test systems. Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST.
| Study group | Role | What they receive |
|---|---|---|
| cases of PJI 2018-2019 | All cases of monomicrobial and polymicrobial periprocthetic infection for 2018-2019. Microbiological identification of pathogens of periprosthetic infections and determination of their sensitivity to antibiotics. Receives: Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistance | |
| cases of PJI 2021-2022 | All cases of monomicrobial and polymicrobial periprocthetic infection for 2021-2022. Microbiological identification of pathogens of periprosthetic infections and determination of their sensitivity to antibiotics. Receives: Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structure of isolated pathogens of periprosthetic infection
The proportion of identified microorganisms in the general structure of pathogens of periprosthetic infection
Measured: 2018-2019
Structure of isolated pathogens of periprosthetic infection
The proportion of identified microorganisms in the general structure of pathogens of periprosthetic infection
Measured: 2021-2022
Secondary outcomes (2)
Antibiotic resistance of isolated pathogens of periprosthetic infection
Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2018 (studies in 2018-2019).
Measured: 2018-2019
Antibiotic resistance of isolated pathogens of periprosthetic infection
Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2021 (studies in 2021-2022).
Measured: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267287
- Sponsor's protocol ID
- 2023-4
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period
- ClinicalTrials.gov ID
- NCT06267287
- Acronym / sponsor ID
- 2023-4
- Keywords
- periprosthetic infection; antibiotic resistance; Staphylococcus epidermidis; pathogens of periprosthetic infection; COVID-19; empirical antibiotic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and ArthroplastyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Feb 2024 (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.
Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods.
Detailed description
A continuous comparative retrospective study of cases of PJI of the joints of the extremities with positive microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods was carried out on the data basis from the medical information system (MIS) of the Federal Center for Traumatology, Orthopedics and Arthroplasty of Ministry of Health of Russia (Cheboksary, Russia), hereinafter referred to as the Center.
Verification of the diagnosis of deep PJI was carried out according to the diagnostic criteria of the Society for Musculoskeletal Infections.
The sample included cases of deep and superficial infection after arthroplasty of the knee, hip, shoulder and wrist joints, regardless of the location of the primary operation. Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment).
The infection was classified as polymicrobial or monomicrobial. The role of the leading pathogen was determined in the structure of monomicrobial infection. Polymicrobial infection is represented by cases of simultaneous isolation of two or more pathogens in one patient. The antibiotic resistance profile included all isolated pathogens of mono- and polymicrobial PJI.
At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination.
The aspirate from the joint was placed into FA plus, FN plus bottles of the Bact/Alert 3D analyzer (Bio Merieux, France). If the sample volume was insufficient (less than 1 ml), it was inoculated into a vial with Schedler's broth and, when turbid, subcultured onto solid media.
The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. After ultrasonication, 0.5 ml of the resulting liquid was applied to solid media.
Homogenized tissue samples were placed in broth with thioglycollate medium. The cultures were incubated at 37°C for up to 14 days, subcultured on solid nutrient media: on the 1st day - on Columbia, Chocolate and Schedler agars; on the 5th day - on Chocolate and Schedler agar and on the 10th day - only on Schedler agar. For aerobic, anaerobic and capnophilic microorganisms, incubation conditions were created using gas-generating packages.
Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer (Vitec2 compact; Bio Merieux, France) and a semi-automatic analyzer (Multiscan FC; Thermo Fisher, USA) using kits (Erba Lachema, Czech Republic), test systems ("Diagnostic systems", Russia).
Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2018 (studies in 2018-2019), EUCAST 2021 (studies in 2021-2022).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases of PJI 2018-2019 | – | Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistanceAll cases of monomicrobial and polymicrobial periprocthetic infection for 2018-2019. Microbiological identification of pathogens of periprosthetic infections and determination of their sensitivity to antibiotics. |
| cases of PJI 2021-2022 | – | Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistanceAll cases of monomicrobial and polymicrobial periprocthetic infection for 2021-2022. Microbiological identification of pathogens of periprosthetic infections and determination of their sensitivity to antibiotics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample included cases of deep and superficial infection after arthroplasty of the knee, hip, shoulder and wrist joints, regardless of the location of the primary operation. Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment).
Key inclusion criteria (1 listed)
- Clinically confirmed periprosthetic infection
Key exclusion criteria (1 listed)
- No signs of periprosthetic infection
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 |
|---|---|---|
| Microbiological examination of the patient's biological material and determination of antibiotic resistanceAlso: Identification of the infectious agent and determination of antibiotic resistanceIsolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment). At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination. The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer and a semi-automatic analyzer using kits, test systems. Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST. | Diagnostic test | cases of PJI 2018-2019, cases of PJI 2021-2022 |
Primary outcome
Structure of isolated pathogens of periprosthetic infection
Time frame: 2018-2019
The proportion of identified microorganisms in the general structure of pathogens of periprosthetic infection
Structure of isolated pathogens of periprosthetic infection
Time frame: 2021-2022
The proportion of identified microorganisms in the general structure of pathogens of periprosthetic infection
2 secondary outcomes
Antibiotic resistance of isolated pathogens of periprosthetic infection
Time frame: 2018-2019
Antibiotic resistance of isolated pathogens of periprosthetic infection
Time frame: 2021-2022
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 20 Feb 2024.
- Individual participant dataSharing planned: Undecided. On request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Joint Infection and Periprosthetic Left Knee Joint Infection, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
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 20 Feb 2024. 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 Russia. 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?
Structure of isolated pathogens of periprosthetic infection (time frame: 2018-2019). The study lists 2 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 Feb 2024.