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Status unknownNCT03222739Updated Feb 1, 2023

Ultrasound for Scoliosis Diagnostic Evaluation

An interventional study of Ultrasound in Scoliosis Idiopathic and Scoliosis; Juvenile, sponsored by Children's National Research Institute. Status unknown at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Children's National Research Institute · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

Read the detailed description

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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Conditions studied

  • Scoliosis Idiopathic
  • Scoliosis; Juvenile

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03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 344 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Children's National Research Institute is the lead sponsor of 124 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Device Arm

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

    Device: Ultrasound

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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • Children's National Health System
    Washington, District of Columbia 20011, United States
    • Jonise · Contact
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03222739
Lead sponsor
Children's National Research Institute
Collaborators
Kitware, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Responsible party
Kevin Cleary (Technical Director, Bioengineering Initiative, Children's National Research Institute) — Principal investigator
First posted
Jul 19, 2017
Start date
Mar 14, 2018
Primary completion
Dec 6, 2023 (estimated)
Completion
Dec 6, 2023 (estimated)
Last update
Feb 1, 2023

Study contacts

Jonise Handy-Richards, AAS
Contact
jhandy@childrensnational.org
202-476-4652
Matthew Oetgen, MD
Contact
moetgen@childrensnational.org

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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