3D Ultrasound in Hemophilic Ankles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mechanical Ultrasound.
- Who it may be relevant to
- Registry conditions: Hemophilia. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Can Ultrasound "See" What Clinicians Cannot in Hemophilic Arthropathy? Point-of-Care Ultrasound and Physical Examination Perspectives
Overview
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
- 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.
Primary outcome measures
- 1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI [Time frame: Day 1]
- Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss) [Time frame: Day 1]
Secondary outcome measures (1)
- Integration of 3D ultrasound into Diagnostic Algorithm [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 36220709
- 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. PMID 11384074
Identifiers
NCT: NCT07452575 · 1000055523