Casting Vs Bracing for Idiopathic Early-Onset Scoliosis

Last updated: December 10, 2024
Sponsor: University of Iowa
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Bracing

Casting

Clinical Study ID

NCT04500041
202003169
  • Ages 12-36
  • All Genders

Study Summary

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Eligibility Criteria

Inclusion

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

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 ofdevelopmental delay

Study Design

Total Participants: 71
Treatment Group(s): 2
Primary Treatment: Bracing
Phase:
Study Start date:
February 09, 2021
Estimated Completion Date:
January 30, 2026

Study 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.

Connect with a study center

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • CHU Sainte-Justine

    Montréal, Quebec H3T 1C5
    Canada

    Site Not Available

  • University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • Italian Scientific Spine Institute (ISICO)

    Milano,
    Italy

    Site Not Available

  • Starship Child Health

    Auckland,
    New Zealand

    Site Not Available

  • National University Hospital

    Singapore,
    Singapore

    Site Not Available

  • Acibadem Maslak Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Royal Orthopaedic Hospital

    Birmingham,
    United Kingdom

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Nemours/Alfred I. duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Shriners Hospitals for Children - Tampa

    Tampa, Florida 33612
    United States

    Site Not Available

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Shriners Hospitals for Children - Chicago

    Chicago, Illinois 60707
    United States

    Site Not Available

  • Riley's Hospital for Children at IU Healthcare

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Children's Hospital of Boston

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • Children's Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • St. Louis Children's Hospital/Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • St. Louis Children's Hospital/Washington University

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Morgan Stanley Children's Hospital

    New York, New York 10032
    United States

    Site Not Available

  • Golisano Children's Hospital/University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Doernbecher Children's Hospital / OHSU

    Portland, Oregon 97239
    United States

    Site Not Available

  • Shriners Hospitals for Children - Portland

    Portland, Oregon 97239
    United States

    Site Not Available

  • Children's Hospital of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Shriners Hospitals for Children - Philadelphia

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Sanford Health

    Sioux Falls, South Dakota 57117
    United States

    Site Not Available

  • Campbell Clinic/Le Bonheur Children's Hospital

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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