NCT02801253招募中不适用
Prospective Cohort of Patients With Prosthetic Joint Infection
Groupe Hospitalier Diaconesses Croix Saint-Simon1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2015年9月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors
研究概览
简要总结
Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.
Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.
Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.
详细描述
Large prospective cohort study in a French referral center for bone and joint infections.
Population
- all patients who consented to participate in the study with PJI treated with:
- debridement-synovectomy for acute infection
- with one-stage, two-stage exchange arthroplasty for chronic infection
- other procedures (complete removal of the prosthesis) and antibiotic therapy
- patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy
Outcome:
- Follow-up at least 2 years
- Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.
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
- •Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
- •According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.
- •Major Criteria:
- •Two positive periprosthetic cultures with phenotypically identical organisms, OR
- •A sinus tract communicating with the joint, OR
- •Minor Criteria:
- •Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
- •Elevated synovial fluid white blood cell (WBC)
- •Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)
- •The presence of pus in the joint without known cause
- •Positive histological analysis of periprosthetic tissue
- •A single positive culture
- •Or a PJI which meets the following three criteria:
- •Medical story suggesting prosthetic joint infection.
- •The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.
- •Germ identification in a single sample of fluid aspiration or tissue culture.
- •Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml.
排除标准
- •Patient who does not meet eligibility criteria.
- •Patient lawfully deprived of his liberty.
- •Patient not insured under social security scheme.
结局指标
主要结局
Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors
时间窗: 2 years
次要结局
- Assessment of treatment failure rate in patients with hip and knee PJI 2 years after prolonged suppressive antibiotic therapy in non-operated patients.(2 years)
- Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty.(2 years)
- Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty.(1, 2, 4, 6 years)
- Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty(6 years)
研究者
Dr Valerie ZELLER
infectious diseases specialist
Groupe Hospitalier Diaconesses Croix Saint-Simon
研究点 (1)
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