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Ultrasound for Scoliosis Diagnostic Evaluation

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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)

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

Trial contacts and locations

1

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Central trial contact

Matthew Oetgen, MD; Jonise Handy-Richards, AAS

Data sourced from clinicaltrials.gov

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