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Clinical Trials/NCT04550988
NCT04550988
Unknown
Not Applicable

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

University Hospital, Bonn1 site in 1 country5 target enrollmentFebruary 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sonography
Sponsor
University Hospital, Bonn
Enrollment
5
Locations
1
Primary Endpoint
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
Last Updated
3 years ago

Overview

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?
Registry
clinicaltrials.gov
Start Date
February 8, 2021
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
University Hospital, Bonn
Responsible Party
Principal Investigator
Principal Investigator

PD Dr. Andreas Strauß

Specialist in orthopedics and trauma surgery

University Hospital, Bonn

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 - 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.

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 - 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.

Study Sites (1)

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