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| Name | Class |
|---|---|
| Swedish Orphan Biovitrum | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with severe haemophilia A or B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| feasibility study | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image | 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. | 5 min |
| Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image | 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. | 5 min |
| Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image | 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. | 5min |
| Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image | 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. | 5 min |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B. Haemophilia is an X-linked recessive genetic bleeding disease characterised by absence or deficiency of factor VIII in haemophilia A or factor IX in haemophilia B. This can cause spontaneous bleedings, particularly into joints. Joint bleedings initiate an inflammatory process characterised by chronic synovitis that causes degeneration of the affected joints and results in haemophilic arthropathy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Strauß, PD Dr. | Contact | 004922828714176 | andreas.strauss@ukbonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Strauß, PD Dr. | Medicine of the University of Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bonn | Recruiting | Bonn | Northrhine Westfalia | 53127 | Germany |
The publication of anonymous patient data is not allowed by informed consent.
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005240 | Feasibility Studies |
| ID | Term |
|---|---|
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |