NCT04154202Unknown不适用
The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools..
研究概览
简要总结
This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening.
The proposed study will be presented to the ethical committee of the medical center and will be started once approved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.
排除标准
- •Patients younger than 18 years;
- •Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (<3 months) fractures around the prosthesis;
- •Pathological fractures (e.g. Metastatic).
结局指标
主要结局
To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools..
时间窗: 1 year
次要结局
未报告次要终点
研究者
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