Prosthetic-joint InfectionNCT05440032
LE as a Marker for Periprosthetic Joint Infection
An observational study of Prosthetic-joint Infection, run by Center for Innovation and Research Organization at 8 sites in United States.
Trial summary
Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- Semi-quantitative electrochemical leukocyte esterse test strip and Roche Chemstrip
- How many people
- 160 participants
- Where
- 8 sitesUnited States
- Study dates
- 7 Dec 2023to Mar 2024
- 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: Subjects undergoing planned aseptic revision surgery to replace part or all of their hip or knee implant or subjects undergoing planned revision for infection
Who may be able to join
- Age greater than 18 years
- Willing and able to sign the informed consent document
- Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.
Who cannot join
- Subjects with known active crystalline deposition disease (e.g. gout)
- Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
- Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
- Subjects undergoing a second-stage re-implantation procedure for PJI
- Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed.
- Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Colorado Joint Replacement
Denver, Colorado, 80210
Clinical Research Manager, 303-260-2940
- Not yet recruiting
University of Louisville
Louisville, Kentucky, 40202
Clinical Research Coordinator, 502-587-8222 ext. 65585
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Clinical Research Manager, 304-293-2485
- Not yet recruiting
JIS Orthopaedics
New Albany, Ohio, 43054
Clinical Research Coordinator, 614-964-0348
- Not yet recruiting
New York University
New York, New York, 10016
Clinical Research Manager, 212-598-6245
- Not yet recruiting
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Clinical Research Coordinator, 267-339-3613
- Not yet recruiting
University of Rochester
Rochester, New York, 14618
Clinical Research Manager, 585-341-9303
- Not yet recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Clinical Research Coordinator
About this study
Official title: Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection
Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test
Read the detailed description
The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.
- Conditions
- Prosthetic-joint Infection
- Being tested
- Semi-quantitative electrochemical leukocyte esterse test strip, Roche Chemstrip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-quantitative electrochemical leukocyte esterse test stripDiagnostic test
Electrochemical assay to detect level of leukocyte esterase in sample
Roche ChemstripDiagnostic test
Urinalysis chemstrip
| Study group | Role | What they receive |
|---|---|---|
| Synovial fluid testing with semi-quantitative leukocyte esterase test strip | Using a drop of synovial fluid, sample will be analyzed via the point-of-care device to measure amount of leukocyte esterase in the sample Receives: Diagnostic Test: Semi-quantitative electrochemical leukocyte esterse test strip | |
| Synovial fluid testing with Roche Chemstrip | Using a drop of synovial fluid, sample will be analyzed via a urine test-strip to measure amount of leukocyte esterase in the sample Receives: Diagnostic Test: Roche Chemstrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+)
Measured: Within one hour of fluid aspiration
Secondary outcomes (1)
Correlation of leukocyte esterase and synovial white blood cell count
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start7 Dec 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440032
- Sponsor's protocol ID
- LE001
- Status last verified
- Jan 2024
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT05440032
- Acronym / sponsor ID
- LE001
- Conditions
- Prosthetic-joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 30 Jun 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.
Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test
Detailed description
The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synovial fluid testing with semi-quantitative leukocyte esterase test strip | – | Diagnostic Test: Semi-quantitative electrochemical leukocyte esterse test stripUsing a drop of synovial fluid, sample will be analyzed via the point-of-care device to measure amount of leukocyte esterase in the sample |
| Synovial fluid testing with Roche Chemstrip | – | Diagnostic Test: Roche ChemstripUsing a drop of synovial fluid, sample will be analyzed via a urine test-strip to measure amount of leukocyte esterase in the sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing planned aseptic revision surgery to replace part or all of their hip or knee implant or subjects undergoing planned revision for infection
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Willing and able to sign the informed consent document
- Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.
Key exclusion criteria (6 listed)
- Subjects with known active crystalline deposition disease (e.g. gout)
- Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
- Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
- Subjects undergoing a second-stage re-implantation procedure for PJI
- Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed.
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 |
|---|---|---|
| Semi-quantitative electrochemical leukocyte esterse test stripElectrochemical assay to detect level of leukocyte esterase in sample | Diagnostic test | Synovial fluid testing with semi-quantitative leukocyte esterase test strip |
| Roche ChemstripUrinalysis chemstrip | Diagnostic test | Synovial fluid testing with Roche Chemstrip |
Primary outcome
Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+)
Time frame: Within one hour of fluid aspiration
1 secondary outcome
Correlation of leukocyte esterase and synovial white blood cell count
Time frame: Within 30 days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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.
8 sites 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 Center for Innovation and Research Organization at 8 sites in United States.
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 3 inclusion and 6 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Contact Tiffany Morrison (717-856-1202, tiffany@parvizisurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+) (time frame: Within one hour of fluid aspiration). 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 30 Jan 2024.