Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection

Обзор

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.

Вмешательства

• Устройство Joint aspiration
  Joint puncture to extract joint fluid.

Первичные конечные точки

• Joint fluid target protein detection [Срок оценки: One day before surgery or one day after surgery]

Вторичные конечные точки (12)

• X-ray [Срок оценки: One day before surgery and two years after surgery]
• Erythrocyte sedimentation rate (ESR) [Срок оценки: One day before sugery and two year after surgery]
• C-reactive protein (CRP) [Срок оценки: One day before sugery and two year after surgery]
• Synovial fluid white blood cell count (SF-WBC) [Срок оценки: One day before surgery and one day after surgery]
• Synovial fluid polymorphonuclear cells (SF-PMN) [Срок оценки: One day before surgery and one day after surgery]
• Doppler lower extremity vascular color ultrasound [Срок оценки: One day before surgery and three day after surgery]
• American Knee Society Score (AKS score) [Срок оценки: One day before surgery, two years after surgery]
• The Hip Harris Score (HHS) [Срок оценки: One day before surgery, two years after surgery]
• Alanine Aminotransferase (ALT) [Срок оценки: One day before surgery and one day after surgery]
• Aspartate Aminotransferase (AST) [Срок оценки: One day before surgery and one day after surgery]
• Serum Creatinine [Срок оценки: One day before surgery and one day after surgery]
• Blood Urea Nitrogen （BUN） [Срок оценки: One day before surgery and one day after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06467734 · XJ202405-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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