Scoliosis Idiopathic, Scoliosis; Juvenile
Conditions
Brief summary
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.
Detailed description
All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.
Interventions
DEVICEUltrasound
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.
Sponsors
Kitware, Inc.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Children's National Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single-arm unblinded group of patients will receive ultrasound imaging of spine.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* All patients ages 7-17 years who present to Dr. Matthew Oetgen in the Department of Orthopaedic Surgery & Sports Medicine for clinical evaluation of scoliosis, * Scoliosis curve type to include adolescent idiopathic (AIS) or juvenile, and * Have x-rays taken as part of clinical evaluation
Exclusion criteria
* Not willing or able to provide consent, or * Had x-rays taken at an outside facility, or * Any underlying neuromuscular condition or syndrome and congenital deformities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imaging | 3 years | 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 |
Countries
United States
Contacts
Primary ContactJonise Handy-Richards, AAS
Backup ContactMatthew Oetgen, MD
Outcome results
None listed