NCT03222739

Ultrasound for Scoliosis Diagnostic Evaluation

Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis Idiopathic
• Scoliosis; Juvenile

Interventions

Type	Name	Description
DEVICE	Ultrasound	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.

Timeline

• Start date: 2018-03-14
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2017-07-19
• Last updated: 2023-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study