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NCT Number: NCT07452575

3D Ultrasound in Hemophilic Ankles

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.

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

Secondary outcomes

  1. Integration of 3D ultrasound into Diagnostic Algorithm

    Time frame: Day 1

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

Other outcomes

  1. Feasibility and Image Quality of 3D ultrasound

    Time frame: Day 1

    Proportion of successful scans without technical failure

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Project Manager

CONTACT

+416-813-7654 ext. x302482

Principal Investigator

CONTACT

[email protected]

+416-813-6079

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Western University, Canada

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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