Sonography and Haemophilia

Overview

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?

Full Title of Study: “Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2022

Interventions

  • Other: feasibility 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.

Arms, Groups and Cohorts

  • Adult patients with severe haemophilia A or B
    • 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 pseudonymised data

Clinical Trial Outcome Measures

Primary Measures

  • Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol – Anterior mid-sagittal ultrasound image
    • Time Frame: 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 – Anterolateral transverse ultrasound image
    • Time Frame: 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 – Transverse ultrasound image – Transverse ultrasound image
    • Time Frame: 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.
  • Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol – Coronal ultrasound image
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Bonn
  • Collaborator
    • Swedish Orphan Biovitrum
  • Provider of Information About this Clinical Study
    • Principal Investigator: PD Dr. Andreas Strauß, Specialist in orthopedics and trauma surgery – University Hospital, Bonn
  • Overall Official(s)
    • Andreas Strauß, PD Dr., Principal Investigator, Medicine of the University of Bonn
  • Overall Contact(s)
    • Andreas Strauß, PD Dr., 004922828714176, andreas.strauss@ukbonn.de

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