About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.);
Trial population
Patients diagnosed with periprosthesis infection or non-periprosthesis infection
Trial design
Case-control
Prospective
Treatments tested in this trial
Joint aspiration
DeviceJoint puncture to extract joint fluid.
Treatment groups
Trial outcomes
Primary outcomes
Joint fluid target protein detection
To detect new target proteins by elisa test.
Secondary outcomes
X-ray
X-ray of surgery site.
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)
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).
Synovial fluid white blood cell count (SF-WBC)
Synovial fluid white blood cell count (SF-WBC)
Locations
Sponsors and contacts
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