Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
研究概览
简要总结
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device:
The following questions will be answered:
- What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia?
- Is it possible to train patients with haemophilia to perform sonography of their target joints?
- Does a patient-based ultrasound monitoring with a handheld device work in a home setting?
- What is the quality of the patient's self-acquired ultrasound images?
- Will the test persons be able to distinguish normal findings from (any) pathologic findings?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
- •No professional medical background
- •Submitted written consent to participate in the study and to use their study related pseudonymized data
排除标准
- •Patients suffering from other bleeding diseases
- •Participants < 18 years of age
- •Participants without written consent
- •Professional medical background
结局指标
主要结局
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
时间窗: 5 min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterolateral transverse ultrasound image. Patellofemoral joint, lateral parapatellar recess, lateral patellar retinaculum and lateral femoral condyle must be visible.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image
时间窗: 5 min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Coronal ultrasound image. Medial meniscus, boundaries of the femur, boundaries of the tibia must be visible.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image
时间窗: 5 min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterior mid-sagittal ultrasound image. Patella, distal femur, suprapatellar recess, suprapatellar fat pad and prefemoral fat pad must be visible.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image
时间窗: 5min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Transverse ultrasound image. Medial facets of the trochlea, lateral facets of the trochlea and cartilage must be visible.
次要结局
未报告次要终点
研究者
PD Dr. Andreas Strauß
Specialist in orthopedics and trauma surgery
University Hospital, Bonn