Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint InfectionYesNCT06467734
Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
An observational study of Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection, run by First Affiliated Hospital of Xinjiang Medical University.
Trial summary
Prosthetic Joint Infection (PJI) is one of the severe complications following arthroplasty. With the global aging population, the number of patients undergoing primary joint replacement surgeries is increasing, leading to a rise in PJI cases. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
- What is being tested?
- Joint aspiration
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with periprosthesis infection or non-periprosthesis infection
Who may be able to join
- Age ≥18 years old, gender is not limited;
- The experimental group met the diagnostic criteria of chronic periprosthesis infection after joint replacement according to the 2018 Musculoskeletal Infection Association; The control group was eligible for primary replacement patients who excluded periprosthesis infection.
- Voluntary and signed informed consent.
Who cannot join
- Patients with immune-related arthritis such as rheumatoid and rheumatism were excluded;
- Radiotherapy and chemotherapy are required due to neoplastic diseases;
- Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
- Severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
- Have a history of drug abuse;
- Use immunosuppressive drugs to treat bone marrow or other transplants;
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- Pregnant, parturient and lactating women;
- Participating in other clinical trials;
- Researchers consider other reasons not appropriate for clinical trial participants.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Prosthetic Joint Infection (PJI) is one of the severe complications following arthroplasty. With the global aging population, the number of patients undergoing primary joint replacement surgeries is increasing, leading to a rise in PJI cases. Although the incidence of PJI is generally low, the impact on patients can be catastrophic. Once an infection occurs, it is further complicated by the rising global antibiotic resistance, imposing a significant economic burden on patients. Therefore, improving the diagnostic rate of PJI is crucial. Currently, various infection markers are used in the diagnosis of PJI. However, there is still a lack of highly sensitive and specific markers to effectively diagnose PJI, necessitating the exploration of new infection markers. This study aims to investigate novel infection markers for the diagnosis of PJI, providing evidence for its diagnosis and subsequent treatment. In this research, we will prospectively collect data from patients undergoing primary joint replacement and those developing PJI from June 2024 to December 2026. These patients will be categorized into non-infection and infection groups. By collecting and analyzing general patient data, surgery-related information, and infection-related indicators from preoperative joint fluid and blood samples, we aim to further evaluate the predictive value of these infection markers for PJI.
- Being tested
- Joint aspiration
- Keywords
- Prospective cohort study, synovial biomarkers, diagnosis, prediction, periprosthetic joint infection
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint aspirationDevice
Joint puncture to extract joint fluid.
| Study group | Role | What they receive |
|---|---|---|
| Infection group | Joint puncture to extract joint fluid Receives: Device: Joint aspiration | |
| None infection group | Joint puncture to extract joint fluid Receives: Device: Joint aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint fluid target protein detection
To detect new target proteins by elisa test.
Measured: One day before surgery or one day after surgery
Secondary outcomes (12)
X-ray
X-ray of surgery site.
Measured: One day before surgery and two years after surgery
Erythrocyte sedimentation rate (ESR)
It measures the rate at which red blood cells settle to the bottom of a test tube within one hour.
Normal ranges:
Male: 0 to 15 millimeters per hour (mm/hr) Female: 0 to 20 millimeters per hour (mm/hr)
Measured: One day before sugery and two year after surgery
C-reactive protein (CRP)
C-reactive protein (CRP) is a protein produced by the liver that significantly increases in response to inflammation or infection. Normal range for CRP is less than 10 milligrams per liter (mg/L).
Measured: One day before sugery and two year after surgery
Synovial fluid white blood cell count (SF-WBC)
Synovial fluid white blood cell count (SF-WBC)
Measured: One day before surgery and one day after surgery
Synovial fluid polymorphonuclear cells (SF-PMN)
Polymorphonuclear neutrophil percentage in synovial fluid refers to the proportion or percentage of polymorphonuclear neutrophils (PMN) present in the synovial fluid. This measurement is important in the assessment of joint health and inflammation, particularly in conditions such as arthritis and infections affecting the joints. Normal range: Less than 80%.
Measured: One day before surgery and one day after surgery
Doppler lower extremity vascular color ultrasound
Doppler lower extremity vascular color ultrasound to evaluate the deep vein thrombus development
Measured: One day before surgery and three day after surgery
American Knee Society Score (AKS score)
American Knee Society Score is used to evaluate the outcomes of knee replacement surgery. This scoring system consists of two main components: the knee score and the function score.
Knee Score: This primarily assesses the condition of the knee joint itself, including pain, stability, and range of motion. The higher of the score, the better of the functional result.
Measured: One day before surgery, two years after surgery
The Hip Harris Score (HHS)
The Harris Hip Score (HHS) is a widely used clinical tool for assessing the outcomes of hip surgeries, particularly hip replacements. Developed by Dr. William Harris in 1969, it evaluates various aspects of hip function and pain to provide an overall score that reflects the patient's condition. The higher the score, the better the result is.
Measured: One day before surgery, two years after surgery
Alanine Aminotransferase (ALT)
An enzyme found in the liver that helps convert proteins into energy. Elevated levels indicate liver damage. Normal range: 10 to 40 units per liter (U/L)
Measured: One day before surgery and one day after surgery
Aspartate Aminotransferase (AST)
An enzyme found in the liver and other tissues. High levels can indicate liver damage but are less specific than ALT. Normal range: 10 to 40 units per liter (U/L)
Measured: One day before surgery and one day after surgery
Serum Creatinine
Measures the level of creatinine in the blood. Elevated levels can indicate impaired kidney function. Normal range: 62 to 115 micromoles per liter (µmol/L).
Measured: One day before surgery and one day after surgery
Blood Urea Nitrogen （BUN）
Measures the amount of nitrogen in the blood that comes from urea. Elevated BUN levels can indicate impaired kidney function. Normal range: 2.5 to 7.1 millimoles per liter (mmol/L).
Measured: One day before surgery and one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Hua, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467734
- Sponsor's protocol ID
- XJ202405-02
- Acronym
- Yes
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be acquired from corresponding author by reasonable reason.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT06467734
- Acronym / sponsor ID
- Yes / XJ202405-02
- Keywords
- Prospective cohort study, synovial biomarkers, diagnosis, prediction, periprosthetic joint infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jun 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.
Prosthetic Joint Infection (PJI) is one of the severe complications following arthroplasty. With the global aging population, the number of patients undergoing primary joint replacement surgeries is increasing, leading to a rise in PJI cases. Although the incidence of PJI is generally low, the impact on patients can be catastrophic. Once an infection occurs, it is further complicated by the rising global antibiotic resistance, imposing a significant economic burden on patients. Therefore, improving the diagnostic rate of PJI is crucial. Currently, various infection markers are used in the diagnosis of PJI. However, there is still a lack of highly sensitive and specific markers to effectively diagnose PJI, necessitating the exploration of new infection markers. This study aims to investigate novel infection markers for the diagnosis of PJI, providing evidence for its diagnosis and subsequent treatment. In this research, we will prospectively collect data from patients undergoing primary joint replacement and those developing PJI from June 2024 to December 2026. These patients will be categorized into non-infection and infection groups. By collecting and analyzing general patient data, surgery-related information, and infection-related indicators from preoperative joint fluid and blood samples, we aim to further evaluate the predictive value of these infection markers for PJI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection group | – | Device: Joint aspirationJoint puncture to extract joint fluid |
| None infection group | – | Device: Joint aspirationJoint puncture to extract joint fluid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with periprosthesis infection or non-periprosthesis infection
Key inclusion criteria (3 listed)
- Age ≥18 years old, gender is not limited;
- The experimental group met the diagnostic criteria of chronic periprosthesis infection after joint replacement according to the 2018 Musculoskeletal Infection Association; The control group was eligible for primary replacement patients who excluded periprosthesis infection.
- Voluntary and signed informed consent.
Key exclusion criteria (9 listed)
- Patients with immune-related arthritis such as rheumatoid and rheumatism were excluded;
- Radiotherapy and chemotherapy are required due to neoplastic diseases;
- Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
- Severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
- Have a history of drug abuse;
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 |
|---|---|---|
| Joint aspirationJoint puncture to extract joint fluid. | Device | Infection group, None infection group |
Primary outcome
Joint fluid target protein detection
Time frame: One day before surgery or one day after surgery
To detect new target proteins by elisa test.
12 secondary outcomes
X-ray
Time frame: One day before surgery and two years after surgery
Erythrocyte sedimentation rate (ESR)
Time frame: One day before sugery and two year after surgery
C-reactive protein (CRP)
Time frame: One day before sugery and two year after surgery
Synovial fluid white blood cell count (SF-WBC)
Time frame: One day before surgery and one day after surgery
Synovial fluid polymorphonuclear cells (SF-PMN)
Time frame: One day before surgery and one day after surgery
Doppler lower extremity vascular color ultrasound
Time frame: One day before surgery and three day after surgery
American Knee Society Score (AKS score)
Time frame: One day before surgery, two years after surgery
The Hip Harris Score (HHS)
Time frame: One day before surgery, two years after surgery
Alanine Aminotransferase (ALT)
Time frame: One day before surgery and one day after surgery
Aspartate Aminotransferase (AST)
Time frame: One day before surgery and one day after surgery
Serum Creatinine
Time frame: One day before surgery and one day after surgery
Blood Urea Nitrogen （BUN）
Time frame: One day before surgery and one day after surgery
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 21 Jun 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be acquired from corresponding author by reasonable reason.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection, run by First Affiliated Hospital of Xinjiang Medical University.
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 9 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: opening soon, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Long Hua, M.D. (+8615099182364, hualong_xmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint fluid target protein detection (time frame: One day before surgery or one day after surgery). 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 21 Jun 2024.