Health TrialsbyHealthPanel

3D Ultrasound in Hemophilic Ankles

ConditionHemophilia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorThe Hospital for Sick Children

About this trial

The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of hemophilia A or B or other bleeding disorders

Cooperative patients

Previous study joint bleed (by history) or suspicion of an acute joint bleed

Disqualifiers

Co-morbid chronic illnesses causing osteoarticular findings

MRI contraindications

Trial design

Design model

Single group

Treatments tested in this trial

  • Mechanical Ultrasound

    Device

    3D ultrasound imaging is a non-invasive technique. The device consists of a stationary platform and a water-filled rotating drum designed to acquire 3D ultrasound images of the ankles. An ultrasound transducer is mounted on a mechanical arm, which positions and orients it toward the rotating axis of the drum. The collected ultrasound images will be mapped into 3D space, and the volume will be reconstructed using software developed by the manufacturer.

Treatment groups

11 Participants
are divided into 1 treatment group
Group A: Hemophilic ParticipantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI

Proportion of correctly classified cases comparing 3DUS findings against full ultrasoind and MRI (reference standard)

Time frame
Day 1
2

Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss)

Findings will be measured as normal, mild, moderate and severe

Time frame
Day 1

Secondary outcomes

1

Integration of 3D ultrasound into Diagnostic Algorithm

Number of cases where 3DUS prevents the need for MRI or full ultrasound or improves detection of early arthropathy.

Time frame
Day 1

Other outcomes

1

Feasibility and Image Quality of 3D ultrasound

Proportion of successful scans without technical failure

Time frame
Day 1

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Western University, Canada

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: