Can Ultrasound "See" What Clinicians Cannot in Hemophilic Arthropathy? Point-of-Care Ultrasound and Physical Examination Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 11
- 主要终点
- 1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI
研究概览
简要总结
The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemophilia A or B or other bleeding disorders
- •Cooperative patients
- •Previous study joint bleed (by history) or suspicion of an acute joint bleed
排除标准
- •Co-morbid chronic illnesses causing osteoarticular findings
- •MRI contraindications
研究组 & 干预措施
Hemophilic Participant
Participants will undergo a 3D ultrasound of an ankle joint performed by a mechanical arm (intervention), a standard ultrasound, and an MRI of the study joint for comparison.
干预措施: Mechanical Ultrasound (Device)
结局指标
主要结局
1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI
时间窗: Day 1
Proportion of correctly classified cases comparing 3DUS findings against full ultrasoind and MRI (reference standard)
Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss)
时间窗: Day 1
Findings will be measured as normal, mild, moderate and severe
次要结局
- Integration of 3D ultrasound into Diagnostic Algorithm(Day 1)
研究者
Andrea Doria
Radiologist
The Hospital for Sick Children