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| Name | Class |
|---|---|
| Western University, Canada | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilic Participant | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Image Quality of 3D ultrasound | Proportion of successful scans without technical failure | Day 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | +416-813-6079 | andrea.doria@sickkids.ca | |
| Clinical Research Project Manager | Contact | +416-813-7654 | x302482 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36220709 | Background | 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. | |
| 11384074 | Background | 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. |
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De-identified participant-level data underlying published findings, along with related documents such as the study protocol and statistical analysis plan.
Beginning 1 month and ending 3 years after the publication of results
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.
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |