Ultrasound for Scoliosis Diagnostic Evaluation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 7 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03222739
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's National Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis Idiopathic, Scoliosis; Juvenile
Additional Details

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

Arms & Interventions

Arms

Other: Device Arm

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

Interventions

Device: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's National Health System, Washington, District of Columbia

Status

Recruiting

Address

Children's National Health System

Washington, District of Columbia, 20011

Site Contact

Jonise

[email protected]

202-476-4652