Ultrasound for Scoliosis Diagnostic Evaluation

Overview

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 Title of Study: “Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 6, 2023

Detailed Description

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Imaging
    • Time Frame: 3 years
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s National Research Institute
  • Collaborator
    • Kitware, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kevin Cleary, Technical Director, Bioengineering Initiative – Children’s National Research Institute
  • Overall Contact(s)
    • Jonise Handy-Richards, AAS, 202-476-4652, jhandy@childrensnational.org

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