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| ID | Type | Description | Link |
|---|---|---|---|
| R01EB021396-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kitware, Inc. | UNKNOWN |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.
All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Arm | Other | This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | An industry standard ultrasound will be fitted with a self-tracking probe to track along the spine. The ultrasound will be performed three (3) times along the spine at initial consultation for scoliosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging | Ability of the ultrasound to produce a radiographic measurement (e.g. coronal spinal curvature, coronal spinal rotation) within the variability of the gold standard of x-ray | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonise Handy-Richards, AAS | Contact | 202-476-4652 | jhandy@childrensnational.org | |
| Matthew Oetgen, MD | Contact | moetgen@childrensnational.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Health System | Recruiting | Washington D.C. | District of Columbia | 20011 | United States |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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A single-arm unblinded group of patients will receive ultrasound imaging of spine.
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