Casting vs Bracing for Idiopathic Early-Onset Scoliosis (CVBT)

March 11, 2026 updated by: Stuart L. Weinstein, MD, University of Iowa
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Italian Scientific Spine Institute (ISICO)
  • New Zealand
      • Auckland, New Zealand
        • Starship Child Health
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours/Alfred I. duPont Hospital for Children
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60707
        • Shriners Hospitals for Children - Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital of Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Gillette Children's Specialty Healthcare
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Kansas City
      • St Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital/Washington University
    • New York
      • Rochester, New York, United States, 14642
        • Golisano Children's Hospital/University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Shriners Hospitals for Children - Portland
      • Portland, Oregon, United States, 97239
        • Doernbecher Children's Hospital / OHSU
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Shriners Hospitals for Children - Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 months (Child)

Accepts Healthy Volunteers

No

Description

Will enroll both patients with scoliosis and 1 of their parents/guardians

Inclusion Criteria:

Patient Inclusion

  • Diagnosis of idiopathic early-onset scoliosis
  • Child standing independently but not older than 3 years of age
  • 20≤ Cobb angle ≤70° (largest structural curvature)
  • Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
  • Parental consent to participate

Parent Inclusion

  • Parent or guardian of the minor subject
  • Consent to participate
  • Able to complete surveys

Exclusion Criteria:

Patient Exclusion

  • Previous operative or non-operative treatment for idiopathic early-onset scoliosis
  • Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Casting
Subjects will be treated with serial casting
Procedure: Casting
Use of casts applied using corrective maneuvers
Active Comparator: Bracing
Subjects will be treated with full-time orthotics (braces)
Device: Bracing
Use of full-time spinal orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Curve Response
Time Frame: on or before 24 months of treatment

Resolution - curve improvement to <15 degrees (as measured on 2 consecutive radiographs)

Failure

  1. Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50°
  2. Initial Cobb >50°: curve progression of ≥20°

Palliation - 2 years of treatment without resolution or failure
on or before 24 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health-related Quality of Life (HRQOL)
Time Frame: on or before 24 months of treatment
Evaluation of patients' HRQOL as estimated by serial administrations of the Early Onset Scoliosis Questionnaire (EOSQ-24, completed by the parent at baseline and every 6 months, total score range 0-100, higher scores indicate higher level of HRQOL). Within and between treatment arm comparisons will be made.
on or before 24 months of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent and Family Functioning
Time Frame: on or before 24 months of treatment
Evaluation of patients' disease and treatment on parent and family function as estimated by serial administrations of the PedsQL Family Impact Module scores (PedsQL FIM, completed by the parent, total score range 0-100, higher scores indicate less negative impact). Within and between treatment arm comparisons will be made.
on or before 24 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

Orthopedic Research and Education Foundation
Pediatric Spine Study Group

Investigators

  • Principal Investigator: Stuart L Weinstein, MD, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202003169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All study data (assessments and images) will reside in the Pediatric Spine Registry.

IPD Sharing Time Frame

after our planned analyses and publications are completed

IPD Sharing Access Criteria

Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Scoliosis Idiopathic

Clinical Trials on Casting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe