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Sonography and Haemophilia

Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04550988
Enrollment
5
Registered
2020-09-16
Start date
2021-02-08
Completion date
2022-12-31
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia, Sonography

Brief summary

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: 1. What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia? 2. Is it possible to train patients with haemophilia to perform sonography of their target joints? 3. Does a patient-based ultrasound monitoring with a handheld device work in a home setting? 4. What is the quality of the patient's self-acquired ultrasound images? 5. Will the test persons be able to distinguish normal findings from (any) pathologic findings?

Interventions

OTHERfeasibility study

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.

Sponsors

Swedish Orphan Biovitrum
CollaboratorINDUSTRY
University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients suffering from other bleeding diseases * Participants \< 18 years of age * Participants without written consent * Professional medical background

Design outcomes

Primary

MeasureTime frameDescription
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image5 minThe 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 - Anterolateral transverse ultrasound image5 minThe 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 - Transverse ultrasound image - Transverse ultrasound image5minThe 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.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image5 minThe 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.

Countries

Germany

Contacts

Primary ContactAndreas Strauß, PD Dr.
andreas.strauss@ukbonn.de004922828714176

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026