Swiss Revision Cohort: a Nationwide, Multi-center, Prospective Periprosthetic Joint Infection Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 329
- 试验地点
- 5
- 主要终点
- Rate of infection failure
研究概览
简要总结
This study follows patients with infections after a joint replacement over time. During follow-up, treatment outcomes are carefully measured to determine whether the infection can be cured. In addition, factors that may change infection cure rates are examined, including the patient's overall health, the type of bacteria causing the infection, and the surgical and antibiotic treatments used. The goal is to understand what leads to more frequent cure and to improve future care.
详细描述
Diagnostic and therapeutic management of patients with periprosthetic joint infections (PJIs) remains challenging. Successful management of PJI requires revision surgery of the prosthetic joint. The Swiss National Joint Registry (SIRIS) reported two-year revision rates of 2.5% for total hip arthroplasty and 3.3% for total knee arthroplasty in 2023, with infection being the most frequent cause of early revision (27.9% for hips and 20.6% for knees). Despite published guidelines, the management of PJI remains insufficiently standardized, primarily due to heterogeneous clinical presentations and limited availability of rigorous data from prospective studies and randomized controlled trials comparing interventions to improve outcomes. The presence of foreign material with biofilm formation further complicates the diagnosis and treatment of PJI, posing a significant challenge for clinicians necessitating close collaboration among specialists from various medical fields, including orthopaedic surgeons, microbiologists and infectious disease experts. A recent observational study suggests that a multidisciplinary team approach is associated with improved diagnostics, fewer surgeries, reduced length of hospital stay, and higher success rates.
This national cohort aims to describe the epidemiology, clinical phenotypes, management strategies and outcomes of patients with PJI. This is a national, multicentre, prospective, longitudinal, observational cohort study of patients who underwent revision for PJI of the hip, knee, shoulder, elbow or ankle. Participating centres include university or non-university tertiary healthcare facilities located in Switzerland. Episodes include likely and confirmed PJI, as defined by the European Bone and Joint Infection Society (EBJIS) criteria. During routine clinical visits after revision surgery, data are collected and patients are followed-up thereafter for a minimum of two years. The primary objective is infection outcome and secondary objectives include functional outcome and patient satisfaction, and evaluation of host, infection, microbiological and treatment factors associated with treatment failure and poor functional outcomes, both in the overall population and across subgroups. A minimum of 329 patients would be needed to have sufficient statistical power to carry out these analyses.
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
- •≥18 years of age
- •Revision surgery of any large prosthetic joint (i.e., hip, knee, shoulder, ankle, or elbow) performed for a suspected or confirmed periprosthetic joint infections at any of the participating study centres. This includes patients who were previously treated at another hospital and referred to a participating study centre if data on a transferred patient from the previous institution are available, complete, and archived in the institutional patient information system, and the patient underwent at least one surgery at a participating institution.
- •Obtained written informed consent
- •Periprosthetic joint infections diagnosis likely or confirmed according to European Bone and Joint Infection Society criteria
排除标准
- •Documented objection to subsequent use of personal health data
- •Patient follow-up outside of Switzerland
- •Diagnosis "periprosthetic joint infections unlikely" according to European Bone and Joint Infection Society criteria
结局指标
主要结局
Rate of infection failure
时间窗: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Rate of incident periprosthetic joint infection (according to European Bone \& Joint Infection Society criteria) or infection-related death. Types of failure include i) persistent or recurrent PJI with the same pathogen or no detected pathogen (i.e., treatment failure) and ii) a new infection caused by a pathogen different from the index episode.
次要结局
- Percent of adverse events from antibiotic treatment(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Percent requiring surgical intervention(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Mean of range of motion measurement (hip)(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Mean of range of motion measurement (knee)(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Percent using any analgesics(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Percent using walking aids (for lower extremity)(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Mean of EuroQol five-dimensional questionnaire score(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)
- Mean of subjective evaluation of pain(Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.)