Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Joint fluid target protein detection
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Joint fluid target protein detection
时间窗: One day before surgery or one day after surgery
To detect new target proteins by elisa test.
次要结局
- Erythrocyte sedimentation rate (ESR)(One day before sugery and two year after surgery)
- Doppler lower extremity vascular color ultrasound(One day before surgery and three day after surgery)
- Alanine Aminotransferase (ALT)(One day before surgery and one day after surgery)
- X-ray(One day before surgery and two years after surgery)
- C-reactive protein (CRP)(One day before sugery and two year after surgery)
- Synovial fluid white blood cell count (SF-WBC)(One day before surgery and one day after surgery)
- Synovial fluid polymorphonuclear cells (SF-PMN)(One day before surgery and one day after surgery)
- American Knee Society Score (AKS score)(One day before surgery, two years after surgery)
- The Hip Harris Score (HHS)(One day before surgery, two years after surgery)
- Serum Creatinine(One day before surgery and one day after surgery)
- Blood Urea Nitrogen （BUN）(One day before surgery and one day after surgery)
- Aspartate Aminotransferase (AST)(One day before surgery and one day after surgery)
研究者
Long Hua
Doctor
First Affiliated Hospital of Xinjiang Medical University