Ultrasound for Scoliosis Diagnostic Evaluation

Children's National

Status: Enrolling

Conditions: Scoliosis Idiopathic; Scoliosis; Juvenile

Treatments: Device: Ultrasound

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03222739

Pro8456

R01EB021396-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Device Arm

Other group

Description:

This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature.

Treatment:

Device: Ultrasound