3D Ultrasound in Hemophilic Ankles

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemophilia
• Intervention / Treatment: Device: Mechanical Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: +416-813-6079; Email: andrea.doria@sickkids.ca
• Study Contact Backup: Name: Clinical Research Project Manager; Phone Number: x302482 +416-813-7654

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hemophilic Participant; Participants will undergo a 3D ultrasound of an ankle joint performed by a mechanical arm (intervention), a standard ultrasound, and an MRI of the study joint for comparison.

Device: Mechanical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1
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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and Image Quality of 3D ultrasound	Proportion of successful scans without technical failure	Day 1

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Western University, Canada

Publications and helpful links

General Publications

• Rascevska E, Tessier DR, Doria AS, Fenster A. Proof-of-Concept Study of a 3-D Ultrasound Scanner Used for Ankle Joint Assessment. Ultrasound Med Biol. 2023 Jan;49(1):278-288. doi: 10.1016/j.ultrasmedbio.2022.09.002. Epub 2022 Oct 8.
• Fenster A, Downey DB, Cardinal HN. Three-dimensional ultrasound imaging. Phys Med Biol. 2001 May;46(5):R67-99. doi: 10.1088/0031-9155/46/5/201.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; children; hemophilia; mechanical arm
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Hemophilia A
• Other Study ID Numbers: 1000055523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level data underlying published findings, along with related documents such as the study protocol and statistical analysis plan.
• IPD Sharing Time Frame: Beginning 1 month and ending 3 years after the publication of results
• IPD Sharing Access Criteria: De-identified individual participant data (IPD) from this study will be made available to qualified researchers conducting independent, scientifically valid research, contingent upon obtaining any required approvals from an Institutional Review Board (IRB). Eligible researchers may access de-identified, coded participant-level data with no personal health information, along with supporting study documents. Access will occur through a controlled process in which researchers must submit a formal data request, and data-sharing agreements may be executed when needed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No