Ultrasound for Scoliosis Diagnostic Evaluation

NCT03222739 | Unknown FDA Device

• 2 other identifiers: Pro8456R01EB021396-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic; Scoliosis; Juvenile

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Study Arms (1)

Device Arm

OTHER

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

Device: Ultrasound

Interventions

Ultrasound 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.

Device Arm

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• Kitware, Inc.: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20011, United States

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Jonise Handy-Richards, AAS

CONTACT

202-476-4652; jhandy@childrensnational.org

Matthew Oetgen, MD

CONTACT

moetgen@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technical Director, Bioengineering Initiative

Model Details: A single-arm unblinded group of patients will receive ultrasound imaging of spine.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 19, 2017
• Study Start: March 14, 2018
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)