Ultrasound for Scoliosis Diagnostic Evaluation

NCT ID: NCT03222739

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-14

Study Completion Date

2023-12-06

Brief Summary

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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

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

Conditions

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Scoliosis Idiopathic Scoliosis; Juvenile

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single-arm unblinded group of patients will receive ultrasound imaging of spine.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Device Arm

This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature.

Group Type OTHER

Ultrasound

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kitware, Inc.

UNKNOWN

Sponsor Role collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Kevin Cleary

Technical Director, Bioengineering Initiative

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's National Health System

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonise Handy-Richards, AAS

Role: CONTACT

202-476-4652

Matthew Oetgen, MD

Role: CONTACT

Facility Contacts

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Jonise

Role: primary

Other Identifiers

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R01EB021396-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro8456

Identifier Type: -

Identifier Source: org_study_id

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