Prosthetic Joint InfectionNCT04056780
Integrated Microfluidic Systems for Diagnosis of Periprosthetic Joint Infection
An observational study of Prosthetic Joint Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Diagnosing periprosthetic joint infection (PJI) remains a major clinical challenge. The diagnosis of PJI is based on a composition of clinical judgment, serologic test from peripheral blood, synovial fluid cytology and biomarkers, radiography, microbiology, histopathologic evaluation of periprosthetic tissue, and… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Sample collection study
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2020to 31 May 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 20 to 90 years
- All sexes
- Adult, Older adult
Study population: Given the lack of published data regarding the application of 2nd ICM criteria, we will not perform a power analysis for sample size calculation before the study. All consecutive patients undergoing revision total joint arthroplasty (hips and knees) will be eligible for recruitment.
Who may be able to join
- Revision total knee arthroplasty
- Revision total hip arthroplasty
- Sufficiently annotated clinical and laboratory data for classification by the 2018 ICM criteria for PJI
- Sufficient synovial fluid for study methods.
Who cannot join
- Inadequate synovial fluid for analysis
- Adverse local tissue reaction (ALTR)
- Crystalline deposition arthropathy
- Inflammatory arthropathy flare
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Periprosthetic Joint Infection With Synovial Fluid Biomarkers Through Integrated Microfluidic Systems
Diagnosing periprosthetic joint infection (PJI) remains a major clinical challenge. The diagnosis of PJI is based on a composition of clinical judgment, serologic test from peripheral blood, synovial fluid cytology and biomarkers, radiography, microbiology, histopathologic evaluation of periprosthetic tissue, and intraoperative findings. The importance of PJI diagnosis give the subsequent treatment options, like the removal of prosthesis, debridement and prosthesis retention and the time of reimplantation.
Currently, The Second International Consensus Meeting (ICM) has announced its criteria for the diagnosis of PJI. The preoperative diagnosis includes serologic tests (C-reactive protein, D-dimer, and erythrocyte sedimentation rate) and synovial fluid biomarkers (white blood cell and differential, leukocyte esterase and ⍺-defensin). The intraoperative diagnosis includes a single positive culture, positive histology, and positive intraoperative purulence. However, some of the markers used in the 2018 ICM criteria, such as ⍺-defensin, leukocyte esterase, and synovial fluid C-reactive protein, are not available in every hospital and cannot be immediately available to clinicians in decision making.
Read more
The microfluidic technologies have made a notable impact on the evolution of diagnostic tools by providing a rapid and cost-effective platform for the application of immunoassay techniques. The microfluidic system integrates the complex processing steps of the laboratory protocols into a single chip through logical integration and optimization of processes. Chang Gung Memorial Hospital and National Tsing Hua University have conducted preliminary research to confirm the feasibility of their microfluidic systems.
Therefore, the project will develop a "microfluidic biomarker detection chip" to detect the concentrations three important biomarkers for PJI, including ⍺-defensin, leukocyte esterase and C-reactive protein in synovial fluids. This will be a three-year project. In the 1st year, 50 patients who will be scheduled to undergo unilateral revision total joint arthroplasty (RTJA) will be collected with the synovial fluid and tested on a laboratory platform. In the 2nd year, based on laboratory results, 50 patients undergoing RTJAs will be recruited to develop a microfluidic chip system, and their on-chip performance will be fine-tuned and optimized. In the 3rd year, 50 patients undergoing RTJA will be collected, and the verification of the microfluidic system will be realized. This system will be validated in PJIs cohorts in the first stage of debridement and implant removal, in the interim period, and the second stage of reimplantation. It is expected that biomarker detection chip will improve medical distress and bring important information to clinical decision-making.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Sample collection study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collection studyOther
Sample collection and collection of laboratory values
| Study group | Role | What they receive |
|---|---|---|
| Septic group | The septic group will be considered as patients that fulfill the 2018 ICM definition of PJI. Receives: Other: Sample collection study | |
| Aseptic group | The aseptic group will be considered as patients that don't fulfill the 2018 ICM definition of PJI. Receives: Other: Sample collection study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of synovial fluid human ⍺-defensin 1-3 (HNP1-3)
To test synovial fluid ⍺-defensin
Measured: Post-operative period after collect per 40 cases (usually within 180-365 days following surgery)
The value of leukocyte esterase (LE)
To test synovial fluid LE
Measured: Immediate post-operative period (usually within 1-2 days following surgery)
The value of synovial C-reactive protein (CRP)
To test synovial fluid CRP
Measured: Immediate post-operative period (usually within 1-2 days following surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Apr 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 May 2022 (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.
- More trials run by Chang Gung Memorial HospitalThe 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056780
- Sponsor's protocol ID
- 201802127B0
- Status last verified
- Jul 2021
- First submitted
- 11 Aug 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Periprosthetic Joint Infection With Synovial Fluid Biomarkers Through Integrated Microfluidic Systems
- ClinicalTrials.gov ID
- NCT04056780
- Acronym / sponsor ID
- 201802127B0
- Conditions
- Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 14 Aug 2019 (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.
Diagnosing periprosthetic joint infection (PJI) remains a major clinical challenge. The diagnosis of PJI is based on a composition of clinical judgment, serologic test from peripheral blood, synovial fluid cytology and biomarkers, radiography, microbiology, histopathologic evaluation of periprosthetic tissue, and intraoperative findings. The importance of PJI diagnosis give the subsequent treatment options, like the removal of prosthesis, debridement and prosthesis retention and the time of reimplantation.
Currently, The Second International Consensus Meeting (ICM) has announced its criteria for the diagnosis of PJI. The preoperative diagnosis includes serologic tests (C-reactive protein, D-dimer, and erythrocyte sedimentation rate) and synovial fluid biomarkers (white blood cell and differential, leukocyte esterase and ⍺-defensin). The intraoperative diagnosis includes a single positive culture, positive histology, and positive intraoperative purulence. However, some of the markers used in the 2018 ICM criteria, such as ⍺-defensin, leukocyte esterase, and synovial fluid C-reactive protein, are not available in every hospital and cannot be immediately available to clinicians in decision making.
The microfluidic technologies have made a notable impact on the evolution of diagnostic tools by providing a rapid and cost-effective platform for the application of immunoassay techniques. The microfluidic system integrates the complex processing steps of the laboratory protocols into a single chip through logical integration and optimization of processes. Chang Gung Memorial Hospital and National Tsing Hua University have conducted preliminary research to confirm the feasibility of their microfluidic systems.
Therefore, the project will develop a "microfluidic biomarker detection chip" to detect the concentrations three important biomarkers for PJI, including ⍺-defensin, leukocyte esterase and C-reactive protein in synovial fluids. This will be a three-year project. In the 1st year, 50 patients who will be scheduled to undergo unilateral revision total joint arthroplasty (RTJA) will be collected with the synovial fluid and tested on a laboratory platform. In the 2nd year, based on laboratory results, 50 patients undergoing RTJAs will be recruited to develop a microfluidic chip system, and their on-chip performance will be fine-tuned and optimized. In the 3rd year, 50 patients undergoing RTJA will be collected, and the verification of the microfluidic system will be realized. This system will be validated in PJIs cohorts in the first stage of debridement and implant removal, in the interim period, and the second stage of reimplantation. It is expected that biomarker detection chip will improve medical distress and bring important information to clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic group | – | Other: Sample collection studyThe septic group will be considered as patients that fulfill the 2018 ICM definition of PJI. |
| Aseptic group | – | Other: Sample collection studyThe aseptic group will be considered as patients that don't fulfill the 2018 ICM definition of PJI. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Given the lack of published data regarding the application of 2nd ICM criteria, we will not perform a power analysis for sample size calculation before the study. All consecutive patients undergoing revision total joint arthroplasty (hips and knees) will be eligible for recruitment.
Key inclusion criteria (4 listed)
- Revision total knee arthroplasty
- Revision total hip arthroplasty
- Sufficiently annotated clinical and laboratory data for classification by the 2018 ICM criteria for PJI
- Sufficient synovial fluid for study methods.
Key exclusion criteria (4 listed)
- Inadequate synovial fluid for analysis
- Adverse local tissue reaction (ALTR)
- Crystalline deposition arthropathy
- Inflammatory arthropathy flare
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 |
|---|---|---|
| Sample collection studySample collection and collection of laboratory values | Other | Aseptic group, Septic group |
Primary outcome
The value of synovial fluid human ⍺-defensin 1-3 (HNP1-3)
Time frame: Post-operative period after collect per 40 cases (usually within 180-365 days following surgery)
To test synovial fluid ⍺-defensin
The value of leukocyte esterase (LE)
Time frame: Immediate post-operative period (usually within 1-2 days following surgery)
To test synovial fluid LE
The value of synovial C-reactive protein (CRP)
Time frame: Immediate post-operative period (usually within 1-2 days following surgery)
To test synovial fluid CRP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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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 Prosthetic Joint Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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 3 Aug 2021. 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 Taiwan. 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?
The value of synovial fluid human ⍺-defensin 1-3 (HNP1-3) (time frame: Post-operative period after collect per 40 cases (usually within 180-365 days following surgery)). The study lists 3 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 3 Aug 2021.