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Clinical Trials/NCT03222739
NCT03222739
Recruiting
Not Applicable

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

Children's National Research Institute1 site in 1 country30 target enrollmentMarch 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis Idiopathic
Sponsor
Children's National Research Institute
Enrollment
30
Locations
1
Primary Endpoint
Imaging
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2018
End Date
December 6, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Children's National Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Kevin Cleary

Technical Director, Bioengineering Initiative

Children's National Research Institute

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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