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Ultrasound for Scoliosis Diagnostic Evaluation

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ClinicalTrials.gov Identifier: NCT03222739
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
Kitware, Inc.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Kevin Cleary, Children's National Research Institute

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.

Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Scoliosis; Juvenile Device: Ultrasound Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single-arm unblinded group of patients will receive ultrasound imaging of spine.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis Ultrasound

Arm Intervention/treatment
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
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 Measures :
  1. 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



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222739


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

Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20011
Contact: Jonise         
Sponsors and Collaborators
Children's National Research Institute
Kitware, Inc.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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Responsible Party: Kevin Cleary, Technical Director, Bioengineering Initiative, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT03222739    
Other Study ID Numbers: Pro8456
R01EB021396-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases