Ultrasound for Scoliosis Diagnostic Evaluation

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222739
• Other study ID #: Pro8456
• Secondary ID: R01EB021396-01A1
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: December 6, 2023

Study information

• Verified date: January 2023
• Source: Children's National Research Institute
• Contact: Jonise Handy-Richards, AAS
• Phone: 202-476-4652
• Email: jhandy[@]childrensnational.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Juvenile

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Children's National Research Institute	Kitware, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years