Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reinfection
研究概览
简要总结
Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.
详细描述
All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •second-stage of knee reimplantation
- •primary knee replacement in primary knee osteoarthritis
- •fulfillment of International Consensus Meeting 2018 infection criteria
排除标准
- •intraoperative bone defects Anderson Orthopedic Research Institute score >II
- •autoimmune disease
- •peripheral vascular disease
- •congenital or acquired immunodeficiencies
- •lack of pathogens after first-stage
- •multi-bacterial infection
- •multidirectional instability
- •lack of patient consent
研究组 & 干预措施
Stem stabilization
Group of patients with stem endoprosthesis stabilization
干预措施: stabilization with stem (Device)
Sleeve stabilization
Group of patients with sleeve endoprosthesis stabilization
干预措施: stabilization with sleeve (Device)
结局指标
主要结局
Reinfection
时间窗: 2 years
Rate of reinfection in both groups
次要结局
- Loosening radiological signs(2 years)
研究者
Bartosz Paweł
M.D., Ph.D.
Prof A Gruca Teaching Hospital