3D Ultrasound in Hemophilic Ankles

Can Ultrasound "See" What Clinicians Cannot in Hemophilic Arthropathy? Point-of-Care Ultrasound and Physical Examination Perspectives

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07452575

Enrollment

Registered

2026-03-05

Start date

2026-04-01

Completion date

2027-12-31

Last updated

2026-03-05

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

Conditions

Hemophilia

Keywords

hemophilia, ultrasound, mechanical arm, children

Brief summary

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.

Interventions

DEVICEMechanical Ultrasound

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Co-morbid chronic illnesses causing osteoarticular findings * MRI contraindications

Design outcomes

Primary

Measure	Time frame	Description
1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI	Day 1	Proportion of correctly classified cases comparing 3DUS findings against full ultrasoind and MRI (reference standard)
Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss)	Day 1	Findings will be measured as normal, mild, moderate and severe

Secondary

Measure	Time frame	Description
Integration of 3D ultrasound into Diagnostic Algorithm	Day 1	Number of cases where 3DUS prevents the need for MRI or full ultrasound or improves detection of early arthropathy.

Contacts

CONTACTPrincipal Investigator

andrea.doria@sickkids.ca+416-813-6079

CONTACTClinical Research Project Manager

+416-813-7654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026