Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 12
- 主要终点
- Clinical cure at 1 year of initial medical management, defined by the absence of the clinical signs of infection, the inflammatory syndrome (C- Reactive Protein <10 mg / L) and the radiological signs of infection
研究概览
简要总结
The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.
详细描述
The incidence of surgical site infections following the orthopedic surgery is about 1%. The number of prosthesis infections is estimated between 2000 and 2500 new cases a year in France.
Multiple medical and surgical care strategies are possible depending on the acute or chronic presentation, early or delayed antibiotic therapy; antibiotic therapy alone or associated with joint lavage, or with a prosthesis change in one or in two stages; after a long or short period of time, with or without fitting spacer. The practices are very heterogeneous for chronic infections depending on the terrain on which infection occurs and modalities of antibiotic therapy remain controversial. The treatment failure rate at 1 year is estimated at 20%.
The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.
Objectives: To determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure.
The secondary objectives are: To evaluate medical and surgical practices in diagnosis and treatment of hip prosthesis infections; identify the success factors and therapeutic failure of medical and surgical supported hip prosthesis infections in terms of clinical cure; determining management of quality indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 ≥ 18 years of age. Having a first episode of hip prosthesis infection defined by an infectious disease physician on clinical , radiological and microbiological criteria according the clinical practice guidelines of the French-Language Infectious Diseases Society May 13, 2009
- •Signed Informed Consent
- •Supported in one of the participating center (hospitals of Arc Alpin)
- •Covered by health insurance
排除标准
- •Subject < 18 years of age
- •Inability to read and understand the participant's Information
- •Pregnant women
结局指标
主要结局
Clinical cure at 1 year of initial medical management, defined by the absence of the clinical signs of infection, the inflammatory syndrome (C- Reactive Protein <10 mg / L) and the radiological signs of infection
时间窗: 12 months
Clinical cure
次要结局
- Time duration between diagnosis and therapeutic management(12 months)
- Quality of life at one year(12 months)
- Functional sequelae at one year(12 months)
- Total duration of antibiotic therapy(12 months)
- Cumulative length of hospital stay(12 months)
- Gap analysis between observed care and the clinical path(12 months)
- Time duration between first clinical signs and diagnosis(12 months)
- Conservation or removal of hip prosthesis(12 months)