Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
研究概览
简要总结
Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation.
There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.
详细描述
Main objective:
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Secondary objectives:
- Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
- Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
- Evaluation of PSA side effects
- Evaluation of nutritional status
- Evaluation of of PSA termination criteria
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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 aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study
- •Non-eligible patient to surgical treatment
- •Patient eligible to prolonged suppressive antibiotherapy
排除标准
- •patient who does not meet eligibility criteria
- •Patient living or traveling abroad for whom 2 years minimum follow up is impossible.
- •Patient lawfully deprived of his liberty
- •Patient not insured under social security scheme
结局指标
主要结局
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
时间窗: 2 years
Method assessment : Short Form 12 questionary (SF12)
次要结局
- 3. Evaluation of PSA side effects(2 years)
- 4. Evaluation of nutritional status(2 years)
- 5. Evaluation of PSA termination criteria(2 years)
- 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.(2 years)
- 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.(2 years)
研究者
SMARMOR
Director
Groupe Hospitalier Diaconesses Croix Saint-Simon