Periprosthetic Joint InfectionMIDNCT05320354
Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID
An observational study of Periprosthetic Joint Infection and PJI, run by UMC Utrecht at 6 sites in 6 countries.
Trial summary
The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection, PJI
- What is being tested?
- Microbial ID test
- How many people
- 200 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 25 Apr 2022to 1 Dec 2025
- 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: Adult patients with a potentially infected joint implant, who will undergo an articular puncture and/or surgery with harvesting of synovial fluid.
Who may be able to join
- Patient has complaints (pain, stiffness) about the prosthetic joint And has clinical features for joint infection at physical examination (swelling, redness, warm, sinus tract) AND has an elevated serum CRP (>10 mg/L)
- Patient is scheduled for a puncture AND/OR surgery, with harvesting of synovial fluid
- Patient ≥ 18 years of age
- Patient is competent, able, and willing to provide written informed consent
Who cannot join
- Treatment with antibiotics ≤2 weeks prior to puncture and/or surgery;
- Other obvious reason(s) for implant dysfunction, such as: fracture, an implant breakage, a malposition, and/or a tumour.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.
Read the detailed description
In the diagnosis of periprosthetic joint infection (PJI) there is no golden standard test. Multiple definitions for the diagnosis of PJI exist, such as the European Bone and Joint Infection Society (EBJIS)1, Musculoskeletal Infection Society (MSIS)2, and the Infectious Diseases Society of America (IDSA)3. One of the criteria that defines PJI is that there are at least two positive periprosthetic cultures with phenotypically identical organisms. Although these two positive bacterial cultures can certainly be considered proof of PJI, many other criteria are also used, such as a sinus tract, white blood count (WBC), elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR), elevated percentage of neutrophils, and positive alpha defensin. Even when all these criteria are negative, a PJI cannot be excluded. Zimmer Biomet developed the Synovasure® Microbial-ID test that enables early and faster identification of microbial species through detection of microbial antigens responsible for infection.
This is an international multicenter, non-randomized, prospective, non-intervention clinical investigation.The primary objective of this study is to demonstrate the validity of the Microbial-ID test to aid in diagnosis of PJI in terms of sensitivity and specificity. The study population is adult patients with a potentially infected joint implant, who will undergo an articular puncture and/or surgery with harvesting of synovial fluid. In addition to the standard of care procedure for patients with a suspected PJI, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients do not benefit from participating in this study. A separate diagnostic tool will run in parallel but this procedure will not interfere with the patient's current path of diagnostic work up nor will it have an effect on their treatment plan. The results will help the investigators to get more insight in the reliability of the MID-test to detect microbial antigens responsible for the PJI. There are no known disadvantages for the patients taking part in this research.
- Conditions
- Periprosthetic Joint Infection, PJI
- Being tested
- Microbial ID test
- Keywords
- Microbial-ID test, Periprosthetic joint infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial ID testDiagnostic test
Also called Synovasure® Microbial Identification Test, Synovasure® Microbial ID P. acnes Test.
In addition to the standard of care procedure for patients suspected for a periprosthetic joint infection, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach.
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of PJI | Adult patients, both male and female, scheduled for a puncture or surgery of their prosthetic joint due to suspected PJI. Receives: Diagnostic Test: Microbial ID test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the MID-test
Sensitivity of the MID-test based upon the number of subjects with a positive MID-test AND ≥1 positive microbiology culture(s) for the same bacterial species (true positives) and the number of subjects with a negative MID-test AND ≥1 positive microbiology culture(s) for one of the four bacterial species the MID-test is testing for (false negatives).
Measured: after 3 weeks
Specificity of the MID-test
Specificity of the MID-test based upon the number of subjects with a negative MIDtest AND only negative microbiology cultures (true negatives) and the number subjects with a positive MID-test AND only negative microbiology cultures (false positives).
Measured: after 3 weeks
Secondary outcomes (4)
Comparison of MID-test and the MB culture(s) regarding the time-to-result.
Comparison of the time-to-result (elapsing hours between harvesting and test result) of the MID-test and the microbiology culture(s).
Measured: after 3 weeks
Rate of identification of bacterial species by the MID-test and the corresponding MB culture(s).
Rate of identification of bacterial species by the MID-test and the corresponding microbiology culture(s).
Measured: after 3 weeks
Proportion of agreement between the MID-test and the diagnosis of PJI according to the EBJIS definition.
Proportion of agreement between the MID-test and the diagnosis of PJI according to the EBJIS definition as assessed by a blinded investigator.
Measured: after 3 weeks
Rate of "false positives" in the reported low-grade PJIs at ≥1-year follow-up.
Rate of "false positives" (MID test (+) and MB culture (-) at F0) in the reported low-grade (MB (-) and clinical signs (+)) PJIs at ≥1-year follow-up.
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start25 Apr 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Harrie Weinans, UMC Utrecht
- Investigators
- Harrie Weinans, Prof, MD, Principal investigator, H.H.Weinans@umcutrecht.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320354
- Sponsor's protocol ID
- 22-072
- Acronym
- MID
- Status last verified
- Feb 2023
- First submitted
- 1 Apr 2022
- Last updated
- 23 Feb 2023
- 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 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID
- ClinicalTrials.gov ID
- NCT05320354
- Acronym / sponsor ID
- MID / 22-072
- Conditions
- Periprosthetic Joint Infection, PJI
- Keywords
- Microbial-ID test, Periprosthetic joint infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Apr 2022 (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 primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.
Detailed description
In the diagnosis of periprosthetic joint infection (PJI) there is no golden standard test. Multiple definitions for the diagnosis of PJI exist, such as the European Bone and Joint Infection Society (EBJIS)1, Musculoskeletal Infection Society (MSIS)2, and the Infectious Diseases Society of America (IDSA)3. One of the criteria that defines PJI is that there are at least two positive periprosthetic cultures with phenotypically identical organisms. Although these two positive bacterial cultures can certainly be considered proof of PJI, many other criteria are also used, such as a sinus tract, white blood count (WBC), elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR), elevated percentage of neutrophils, and positive alpha defensin. Even when all these criteria are negative, a PJI cannot be excluded. Zimmer Biomet developed the Synovasure® Microbial-ID test that enables early and faster identification of microbial species through detection of microbial antigens responsible for infection.
This is an international multicenter, non-randomized, prospective, non-intervention clinical investigation.The primary objective of this study is to demonstrate the validity of the Microbial-ID test to aid in diagnosis of PJI in terms of sensitivity and specificity. The study population is adult patients with a potentially infected joint implant, who will undergo an articular puncture and/or surgery with harvesting of synovial fluid. In addition to the standard of care procedure for patients with a suspected PJI, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients do not benefit from participating in this study. A separate diagnostic tool will run in parallel but this procedure will not interfere with the patient's current path of diagnostic work up nor will it have an effect on their treatment plan. The results will help the investigators to get more insight in the reliability of the MID-test to detect microbial antigens responsible for the PJI. There are no known disadvantages for the patients taking part in this research.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of PJI | – | Diagnostic Test: Microbial ID testAdult patients, both male and female, scheduled for a puncture or surgery of their prosthetic joint due to suspected PJI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a potentially infected joint implant, who will undergo an articular puncture and/or surgery with harvesting of synovial fluid.
Key inclusion criteria (4 listed)
- Patient has complaints (pain, stiffness) about the prosthetic joint And has clinical features for joint infection at physical examination (swelling, redness, warm, sinus tract) AND has an elevated serum CRP (>10 mg/L)
- Patient is scheduled for a puncture AND/OR surgery, with harvesting of synovial fluid
- Patient ≥ 18 years of age
- Patient is competent, able, and willing to provide written informed consent
Key exclusion criteria (2 listed)
- Treatment with antibiotics ≤2 weeks prior to puncture and/or surgery;
- Other obvious reason(s) for implant dysfunction, such as: fracture, an implant breakage, a malposition, and/or a tumour.
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 |
|---|---|---|
| Microbial ID testAlso: Synovasure® Microbial Identification Test, Synovasure® Microbial ID P. acnes Test.In addition to the standard of care procedure for patients suspected for a periprosthetic joint infection, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach. | Diagnostic test | Patients suspected of PJI |
Primary outcome
Sensitivity of the MID-test
Time frame: after 3 weeks
Sensitivity of the MID-test based upon the number of subjects with a positive MID-test AND ≥1 positive microbiology culture(s) for the same bacterial species (true positives) and the number of subjects with a negative MID-test AND ≥1 positive microbiology culture(s) for one of the four bacterial species the MID-test is testing for (false negatives).
Specificity of the MID-test
Time frame: after 3 weeks
Specificity of the MID-test based upon the number of subjects with a negative MIDtest AND only negative microbiology cultures (true negatives) and the number subjects with a positive MID-test AND only negative microbiology cultures (false positives).
4 secondary outcomes
Comparison of MID-test and the MB culture(s) regarding the time-to-result.
Time frame: after 3 weeks
Rate of identification of bacterial species by the MID-test and the corresponding MB culture(s).
Time frame: after 3 weeks
Proportion of agreement between the MID-test and the diagnosis of PJI according to the EBJIS definition.
Time frame: after 3 weeks
Rate of "false positives" in the reported low-grade PJIs at ≥1-year follow-up.
Time frame: after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Or v IV Antibiotics for Infection
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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.
Harrie Weinans, Prof, MD principal investigator
H.H.Weinans@umcutrecht.nl
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Joint Infection and PJI, run by UMC Utrecht at 6 sites in 6 countries.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Netherlands, Portugal, Slovenia, Spain and 1 more country. 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?
Results are not available in the source record.
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?
Sensitivity of the MID-test (time frame: after 3 weeks). 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 23 Feb 2023.