Casting Vs Bracing for Idiopathic Early-Onset Scoliosis

Not Applicable

Active, not recruiting

• Conditions: Scoliosis Idiopathic; Early-Onset Scoliosis Deformity of Spine

• Registration Number: NCT04500041
• Lead Sponsor: University of Iowa

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Study Start: 2021-02-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Curve Response	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

Secondary Outcome Measures

Name	Time	Method
Patient Health-related Quality of Life (HRQOL)	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.

Trial Locations

Locations (26)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Nemours/Alfred I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Shriners Hospitals for Children - Chicago; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital of Boston; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

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