Insight of Joint Microbiome From Different Knee Conditions.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine the microbiome (bacterial composition) of the knee joint
研究概览
简要总结
Prosthetic joint infection (PJI) is a devastating complication following arthroplasty. An utmost effort has been done to clarify risk factors and microbiology of PJI. We now know the most frequent infecting microorganisms are members of the skin microbiome. These microorganisms are thought to get into the joint and infect the prosthesis during the peri-operative and/or post-operative period. Nevertheless, recent studies have suggested, bacteria may be present in the joint even before the first incision, suggesting the existence of a joint microbiome. Therefore, we aimed to determine the bacterial composition from different knee conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients 18 years or older who give verbal and written informed consent for the retrieval of experimental samples and data collection.
- •Group A: Subjects with lack of Osteoarthritis (OA) evidence, invasive examinations, minor procedures, cartilage damage, and/or synovitis in joints.
- •Group B: Patients undergoing primary knee arthroplasty (partial or total).
- •Group C: Contralateral non-affected (native) joint without knee arthroplasty, history of septic arthritis (SA), invasive examinations and/or minor procedures.
- •Group D: Patients undergoing aseptic knee revision surgery.
- •Group E: Patients undergoing septic knee revision surgery
排除标准
- •Withdrawal of informed consent, suspicion of PJI, surgical site infection (SSI) or septic arthritis (SA) before samples retrieval, use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis), inflammatory arthritis, systemic rheumatic disorder, high risk of infection.
- •Group A: History and/or suspicion before/at samples retrieval of SA in native joint.
- •Group B: History and/or suspicion before/at samples retrieval of SSI or SA in the affected joint.
- •Group C: No additional criterion.
- •Group D: History and/or suspicion before/at samples retrieval of PJI, SSI, SA in the affected joint
- •Group E: No additional criterion.
结局指标
主要结局
Determine the microbiome (bacterial composition) of the knee joint
时间窗: 3 days
Joint fluid taken from the operative knee during surgery will be analyzed using next generation sequencing (NGS).
次要结局
未报告次要终点