Recruiting

Ultrasound

Sponsor:

Children's National Research Institute

Code:

NCT03222739

Conditions

Scoliosis Idiopathic

Scoliosis; Juvenile

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Ultrasound

Study Details

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.

Conditions

Scoliosis Idiopathic

Scoliosis; Juvenile

Study ID

NCT03222739

Start date

Mar 14, 2018

Status verified date

Jan, 2023

Completion date

Dec 6, 2023

Anticipated

Primary completion date

Dec 6, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Imaging [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Jonise Handy-Richards, AAS

202-476-4652jhandy@childrensnational.org

Matthew Oetgen, MD

moetgen@childrensnational.org

Locations

Children's National Health System

Recruiting

Washington, District of Columbia, United States, 20011

More Information

Sponsor

Children's National Research Institute

Last update posted

Feb 1, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2023-02-01.