Back to resultsUltrasound for Scoliosis Diagnostic Evaluation
Primary Purpose
Scoliosis Idiopathic, Scoliosis; Juvenile
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional other trial for Scoliosis Idiopathic
Eligibility 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
Sites / Locations
- Children's National Health SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Device Arm
Arm Description
This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03222739
First Posted
July 13, 2017
Last Updated
January 31, 2023
Sponsor
Children's National Research Institute
Collaborators
Kitware, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT03222739
Brief Title
Ultrasound for Scoliosis Diagnostic Evaluation
Official Title
Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
December 6, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
Collaborators
Kitware, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Scoliosis; Juvenile
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-arm unblinded group of patients will receive ultrasound imaging of spine.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device Arm
Arm Type
Other
Arm Description
This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
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 Information:
Title
Imaging
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonise Handy-Richards, AAS
Phone
202-476-4652
Email
jhandy@childrensnational.org
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Oetgen, MD
Email
moetgen@childrensnational.org
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonise
12. IPD Sharing Statement
Learn more about this trial
Ultrasound for Scoliosis Diagnostic Evaluation
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