European Implant Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Infection Outcome
研究概览
简要总结
The incidence of postoperative PJI is ranging from 0.5-2.5% for primary interventions and are reported up to 20% for revision procedure. In addition, hematogenous PJI can occur at any time after implantation and the risk of infection remains during the entire prosthesis indwelling time. Prosthetic joint infections (PJI) are associated with significant morbidity and costs to the healthcare system. Evidence for optimal management of PJI with best outcome and lowest expenses is limited and recommendations between countries vary significantly. There is unmet need to standardized diagnostic procedures and definition of infection as well as achieve a consensus for uniform treatment guidelines.The European Implant Cohort Study (EICS) is a multicenter European research project, including patients with PJI in a cohort representative for Europe. The EICS is established jointly by the Orthopedic and Traumatology surgeons, Infectious Diseases specialists and microbiologists of selected university and non-university institutions across Europe. The principal aim of the EICS is to improve the management of PJI and develop consensus guidelines across Europe. By systematic analysis of consecutively included patients with PJI, factors associated with best outcome regarding infection (assessed by the infection-free interval) and joint function (assessed by the degree of pain, mobility, range of motion) will be determined in a longitudinal prospective study with long-term follow-up. This is an investigator-initiated, open, prospective, multicenter observational study. Participating study centers will be university or non-university hospitals across Europe, which fulfill the following study conditions:
- Close collaboration between infectious diseases specialists, microbiologists and orthopedic/trauma surgeons,
- Availability of appropriate microbiological methods (following standard recommendations including sonication of removed prosthesis),
- Availability a dedicated study team (study nurse and/or research fellow) for regular eligibility screenings, patient inclusion procedure, real-time data collection and patient follow-up.
This project may generate important scientific evidence for future guidelines regarding management of PJI, has the potential to initiate new multicenter substudies in an establish network, and may open further collaboration and exchange of skills between institutions across Europe.
详细描述
INTRODUCTION
- Objectives
The principal aim of the EICS is to improve the management of PJI and develop consensus guidelines across Europe. By systematic analysis of consecutively included patients with PJI, factors associated with best outcome regarding infection (assessed by the infection-free interval) and joint function (assessed by the degree of pain, mobility, range of motion) will be determined in a longitudinal prospective study with long-term follow-up.
In the EICS evaluable patient groups will be generated enabling the comparison between different surgical and antimicrobial treatment concepts. This study aim will be achieved by:
- Recruitment of patients with PJI of joint prostheses (e.g. hip, knee, shoulder and ankle joints) in participating study centers.
- Systematic collection of clinical, radiological, pharmacological, laboratory, microbiological, treatment and outcome data using a standardized electronic CRF (eCRF)
- Ensuring long-term follow-up of patient with evaluation regarding infection, functional result and health care costs.
- Background
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
- 否
入选标准
- •Subject is older than 18 years of age.
- •Written Informed consent has been obtained.
- •Subject has a prosthetic joint infection (PJI) of the hip, knee or shoulder prosthesis defined as presence of at least one of the following criteria:
- •visible pus around the prosthesis
- •presence of sinus tract (fistula),
- •acute inflammation in histopathology of periprosthetic tissue
- •positive microbiology of synovial fluid, sonication or periprosthetic tissue
- •increased leukocyte count or neutrophil percentage in preoperative synovial fluid aspirate,
- •Subject is willing to participate in the study, to follow protocol study treatment regimen, and to comply with all planned follow-up assessments.
排除标准
- •Subject has been previously enrolled in the study or is currently enrolled in another investigational study, which deviates from the treatment algorithm.
- •Inability to read and understand the participant's information.
结局指标
主要结局
Infection Outcome
时间窗: 2 years
This will be determined as the infection-free interval after end of treatment. Infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening). The expected "cure rate", defined as the infection-free interval at 2 years, is \>80%. The treatment outcome of the combined (antimicrobial and surgical) treatment approach will be assessed in a time-dependent manner using the Kaplan-Meier survival method.
次要结局
- Functional outcome(The following data will be collected at study inclusion, during hospitalization and during follow-up visits (3, 6, 12 months and thereafter as the usual clinical practice):)
研究者
Andrej Trampuz
Medical Doctor
Centre Hospitalier Universitaire Vaudois