Scoliosis Treatment Using Casting or Bracing in Early-Onset Cases

Casting vs. Bracing in Idiopathic Early-Onset Scoliosis Trial

Protocol Description

The purpose of this multi-center international research study is to compare the effectiveness of two treatments – casting and bracing – for idiopathic early-onset scoliosis (IEOS), a curvature of the spine that occurs in children up to 3 years of age for unknown reasons. Casting or bracing are usually done to help decrease the scoliosis curve and to help avoid or delay surgical approaches. Researchers will also evaluate the effect of these treatments on the health, function, behavior, and emotions of children, and how scoliosis treatment affects parent/guardian caregivers.

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting children, ages 12 through 36 months, who have IEOS. The parent/guardian will also have a role in the study.
Boys and Girls: Ages 12 through 36 months, plus parent/guardian

Requirements

Participating children will either be fitted with a cast or brace, based on parental preference or randomization if there is no preference. Both treatments are considered to be “standard of care.” Those receiving casting treatment will require a new cast every three months and those using braces will require brace adjustments at certain intervals. In all cases, imaging will be done every 6 months to determine the degree of curvature correction taking place. Parent participants will complete quality of life questionnaires while their child is undergoing treatment.
Visits: None beyond what is required for the standard of care chosen.
Duration: 2 years

Status: Open to Enrollment

Source(s) of Support

The Orthopaedic Research and Education Foundation
The University of Iowa

Primary Investigator

Timothy Ward, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Coordinator Jennifer Oakley, MPH
412-692-8061