Intraosseous Antibiotics for Osseointegration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 5
研究概览
简要总结
The purpose of this research study is to learn about the characteristics of infection in osseointegration patients. This research study will also study how safe and effective it is to use antibiotics inside the bone.
详细描述
The goal of this multi-center prospective trial is to assess the characteristics of infection among patients with osseointegrated prosthesis and the safety and effectiveness of intraosseous antibiotic delivery.
Participants will enroll in an observational arm. Participants who require surgery for infection may enroll in an interventional arm assessing the safety and feasibility of intraosseous antibiotic administration as a potential treatment for infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Treated with osseointegration for transfemoral, transhumeral, or transtibial amputation and presenting with concern for surgical site infection
- •>18 years of age
排除标准
- •Unable to follow up at site for 1 year
- •Patients that speak neither English nor Spanish
- •<18 years of age
研究组 & 干预措施
Observational
Patients that do not require surgery for infection
Intraosseous Antibiotics for Osseointegration
Patients that require surgery for infection
干预措施: intraosseous antibiotic delivery (Procedure)