Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
NCT Number: NCT06467734
Acronym: Yes
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
Interventions: DEVICE: Joint aspiration
Sponsor: First Affiliated Hospital of Xinjiang Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-12-31

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. 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.

Primary Outcome Measures: Joint fluid target protein detection, To detect new target proteins by elisa test., One day before surgery or one day after surgery
Secondary Outcome Measures: X-ray, X-ray of surgery site., 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), 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)., 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), 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%., 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, 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., 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., 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), 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), 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)., 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)., One day before surgery and one day after surgery