Ultrasound for Scoliosis Diagnostic Evaluation

Not Applicable

Recruiting

• Conditions: Scoliosis; Juvenile; Scoliosis Idiopathic
• Interventions: Device: Ultrasound

• Registration Number: NCT03222739
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Study Start: 2018-03-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-12-06
• Study Completion: 2023-12-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Imaging	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

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States