Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04500041

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Scoliosis Idiopathic Early-Onset Scoliosis Deformity of Spine

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Italian Scientific Spine Institute (ISICO), Milan, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Casting

Procedure

Use of casts applied using corrective maneuvers

Bracing

Device

Use of full-time spinal orthosis

Primary outcomes

  1. Curve Response

    Time frame: on or before 24 months of treatment

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

    Failure

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

    Palliation - 2 years of treatment without resolution or failure

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Orthopedic Research and Education Foundation
  • Pediatric Spine Study Group

Registry information

Acronym: CVBT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2020
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.