NCT01015365已完成不适用
Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 16
- 主要终点
- re-infection
研究概览
简要总结
The investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation, low re-revision rates and good long term results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient with clinical signs of infection for more than 4 weeks, arising from total hip arthroplasty (primary and revision), resurfacing hip arthroplasty or hemi-hip arthroplasty
- •Informed oral and written consent given
排除标准
- •Life expectancy under 2 years
- •Cognitive dysfunction
- •Pre-operative unwillingness to receive blood
- •Intravenous drug abuse
- •Alcoholism
- •Immunocompromised patients
- •Patients receiving immunosuppressive medication
- •Ongoing systemic inflammatory disease
- •Poorly regulated diabetes mellitus
- •Renal failure (requiring dialysis)
- •Acute systemic inflammatory response syndrome with proven infection (sepsis)
- •Signs of coexisting active long-term local infection (i.e. endocarditis)
- •Previous two-stage revision of hip arthroplasty due to ipsilateral chronic infection (regardless of symptom free interval) or contralateral chronic infection (within the last 2 years).
- •< 6 weeks since last surgery of the affected hip
- •If definition of infection is not fulfilled: infection defined as Culture positive: ≥ 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) Culture negative: < 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) + Chronic fistula with history of previous or existing secretion or Positive cultures in pre-operatively joint fluid aspiration with other clinical signs of infection or Visual pus or purulent fluid during exchange procedure with clinical signs of infection
结局指标
主要结局
re-infection
时间窗: 2 years
次要结局
- Revision for other cause than infection(2 years)
研究者
研究点 (16)
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