Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery: A Prospective, Randomized Controlled Trial Study
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
- Infection control rate
研究概览
简要总结
Prosthetic Joint Infection (PJI) is a severe complication following joint replacement surgery, imposing significant economic and health burdens on patients. For acute PJI, the DAIR (Debridement, Antibiotics, and Implant Retention) procedure is a necessary and effective treatment method, as it effectively clears the infection while preserving the prosthesis, thereby avoiding more complex surgical interventions. However, the practice of using drainage tubes postoperatively is controversial. Some studies suggest that drainage tubes may increase the risk of infection, while other literature indicates no statistically significant difference in infection risk associated with their use.In this context, Professor Li Cao's team at Xinjiang Medical University has improved the traditional DAIR procedure by incorporating long-term local antibiotic injections post-surgery, achieving positive results. Despite this, the specific method of antibiotic injection, particularly whether to use a drug infusion tube, remains under debate. The use of an infusion tube can reduce patient discomfort, shorten the local disinfection process, and theoretically decrease the time the incision is exposed to the external environment, potentially lowering the infection risk. However, the validity of these theoretical assumptions needs further confirmation through high-level scientific research. This study aims to evaluate whether there are differences in joint function recovery, changes in blood infection markers, and the incidence of postoperative complications between using and not using an infusion tube for local antibiotic injection after knee DAIR surgery. To assess the value of the infusion tube in local antibiotic injection post-knee DAIR surgery, a randomized controlled trial (RCT) will be conducted. Eligible patients will be randomly assigned to the infusion tube group (experimental group) or the non-infusion tube group (control group). The study will prospectively collect basic information, joint function scores, blood infection markers, and postoperative complication data from both groups, including patient age, gender, educational background, and postoperative blood test results. Ultimately, the RCT aims to demonstrate the therapeutic efficacy of the infusion tube method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Age ≥18 years old, gender is not limited;
- •Meet the diagnostic criteria for DAIR surgery of artificial knee joint;
- •Receiving knee DAIR surgery;
- •Voluntary and signed informed consent.
排除标准
- •Patients with chronic PJI infection undergoing total knee revision;
- •Patients with severe knee joint infection who cannot undergo artificial joint replacement;
- •Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
- •periprosthesis infection after multiple joint replacement;
- •Active infection at the site of intravenous or joint injection;
- •long-term use of anticoagulants or antiplatelet drugs due to other diseases;
- •Have sepsis or positive blood culture within the last 30 days;
- •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;
- •Treatment of bone marrow or other transplants with immunosuppressive drugs;
- •Pregnant, parturient and lactating women;
- •Participating in other clinical trials;
- •Researchers believe that other reasons are not appropriate for clinical trial participants.
结局指标
主要结局
Infection control rate
时间窗: Two year after surgery
Infection control rate
Re-operation rate
时间窗: Two year after surgery
Re-operation rate
Time between infection recurrence
时间窗: Two year after surgery
Time between infection recurrence
次要结局
- C-reactive protein (CRP)(One day before surgery and one day after surgery)
- Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)(One day before surgery, three month after surgery)
- White blood cell count(One day before surgery and one day after surgery)
- Erythrocyte sedimentation rate (ESR)(One day before surgery and one day after surgery)
- Serum Creatinine(One day before surgery and one day after surgery)
- American Knee Society Score (AKS score)(One day before surgery and two years after surgery)
- Visual Analog Scale score(One day before surgery and two years after surgery)
- X-ray(One day before surgery and two years after surgery)
- Synovial fluid white blood count(One day before surgery and one day after surgery)
- Polymorphonuclear neutrophil percentage in synovial fluid (SF-PMN)(One day before surgery and one day after surgery)
- Alanine Aminotransferase (ALT)(One day before surgery and one day after surgery)
- Aspartate Aminotransferase (AST)(One day before surgery and one day after surgery)
- Blood Urea Nitrogen (BUN)(One day before surgery and one day after surgery)
研究者
Long Hua
Doctor
First Affiliated Hospital of Xinjiang Medical University
