Drug Delivery Devices for Osteomyelitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- complications after first-stage surgery.
研究概览
简要总结
Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. The patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 68 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The retrospective study included patients with chronic post-traumatic or postoperative osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute post-traumatic or postoperative osteomyelitis.
排除标准
- •Other kinds of osteomyelitis.
研究组 & 干预措施
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
干预措施: antibiotic-loaded calcium sulfate (Device)
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
干预措施: antibiotic-loaded polymethyl methacrylate (Device)
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
干预措施: Vancomycin (Drug)
PMMA group
antibiotic-loaded polymethyl methacrylate and Vancomycin
干预措施: antibiotic-loaded polymethyl methacrylate (Device)
PMMA group
antibiotic-loaded polymethyl methacrylate and Vancomycin
干预措施: Vancomycin (Drug)
结局指标
主要结局
complications after first-stage surgery.
时间窗: through study completion, an average of 24 months.
local infection recurrence after first-stage surgery.
时间窗: through study completion, an average of 24 months.
次要结局
未报告次要终点
研究者
Shanchao Luo
Director
Yulin Orthopedics Hospital of Chinese and Western Medicine