Casting vs Bracing for Idiopathic Early-Onset Scoliosis

N/AActive Not RecruitingNCT04500041

University of Iowa71 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Scoliosis Idiopathic Early-Onset Scoliosis Deformity of Spine

Interventions

CastingPROCEDURE

Use of casts applied using corrective maneuvers

BracingDEVICE

Use of full-time spinal orthosis

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

Curve Response

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

Time frame: on or before 24 months of treatment

Secondary Outcomes

Patient Health-related Quality of Life (HRQOL)

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.

Time frame: on or before 24 months of treatment

Data from ClinicalTrials.gov

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