Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Joint aspiration.
- Who it may be relevant to
- Registry conditions: Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Joint aspiration
Joint puncture to extract joint fluid.
Primary outcome measures
- Joint fluid target protein detection [Time frame: One day before surgery or one day after surgery]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Pregnant, parturient and lactating women;
- Participating in other clinical trials;
- Researchers consider other reasons not appropriate for clinical trial participants.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06467734 · XJ202405-02