Clinical trial NCT06467734: Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
Official title: Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
Keywords: Prospective cohort study
synovial biomarkers
diagnosis
prediction
periprosthetic joint infection
Lead sponsor: First Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with periprosthesis infection or non-periprosthesis infection

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. 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.
3. Voluntary and signed informed consent.

Exclusion Criteria:

1. Patients with immune-related arthritis such as rheumatoid and rheumatism were excluded;
2. Radiotherapy and chemotherapy are required due to neoplastic diseases;
3. Receiving systemic glucocorticoid therapy (prednisone \> 10mg/ day or equivalent hormone medication);
4. Severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
5. Have a history of drug abuse;
6. Use immunosuppressive drugs to treat bone marrow or other transplants;
7. Pregnant, parturient and lactating women;
8. Participating in other clinical trials;
9. Researchers consider other reasons not appropriate for clinical trial participants.

Primary outcomes:
measure: Joint fluid target protein detection
timeFrame: One day before surgery or one day after surgery
Secondary outcomes:
measure: X-ray
timeFrame: One day before surgery and two years after surgery
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: One day before sugery and two year after surgery
measure: C-reactive protein (CRP)
timeFrame: One day before sugery and two year after surgery
measure: Synovial fluid white blood cell count (SF-WBC)
timeFrame: One day before surgery and one day after surgery
measure: Synovial fluid polymorphonuclear cells (SF-PMN)
timeFrame: One day before surgery and one day after surgery
measure: Doppler lower extremity vascular color ultrasound
timeFrame: One day before surgery and three day after surgery
measure: American Knee Society Score (AKS score)
timeFrame: One day before surgery, two years after surgery
measure: The Hip Harris Score (HHS)
timeFrame: One day before surgery, two years after surgery
measure: Alanine Aminotransferase (ALT)
timeFrame: One day before surgery and one day after surgery
measure: Aspartate Aminotransferase (AST)
timeFrame: One day before surgery and one day after surgery
measure: Serum Creatinine
timeFrame: One day before surgery and one day after surgery
measure: Blood Urea Nitrogen （BUN）
timeFrame: One day before surgery and one day after surgery
Other outcomes:
Locations:
Study officials:
References: