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Clinical Trials in Italy / NCT04500041
Active, not recruiting Not applicable

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

NCT04500041 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Iowa
Phase
Not applicable
Started
2021-02-09
Last updated
2026-03-13

Condition(s) studied

Scoliosis IdiopathicEarly-Onset Scoliosis Deformity of Spine

Investigational drug(s) / intervention(s)

CastingBracing

Casting: Use of casts applied using corrective maneuvers

Bracing: Use of full-time spinal orthosis

Study summary

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

Eligibility

Sex
ALL
Min age
12 Months
Max age
36 Months
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (26)

FacilityCityRegionStatus
Arkansas Children's Hospital Little Rock Arkansas
Children's Hospital Colorado Aurora Colorado
Nemours/Alfred I. duPont Hospital for Children Wilmington Delaware
Children's Healthcare of Atlanta Atlanta Georgia
Lurie Children's Hospital of Chicago Chicago Illinois
Shriners Hospitals for Children - Chicago Chicago Illinois
University of Iowa Iowa City Iowa
Johns Hopkins Baltimore Maryland
Children's Hospital of Boston Boston Massachusetts
University of Michigan Ann Arbor Michigan
Gillette Children's Specialty Healthcare Saint Paul Minnesota
Children's Mercy Kansas City Kansas City Missouri
St. Louis Children's Hospital/Washington University St Louis Missouri
Golisano Children's Hospital/University of Rochester Rochester New York
University of North Carolina Chapel Hill Chapel Hill North Carolina
Duke University Medical Center Durham North Carolina
Doernbecher Children's Hospital / OHSU Portland Oregon
Shriners Hospitals for Children - Portland Portland Oregon
Children's Hospital of Pennsylvania Philadelphia Pennsylvania
Shriners Hospitals for Children - Philadelphia Philadelphia Pennsylvania
Vanderbilt University Medical Center Nashville Tennessee
Texas Children's Hospital Houston Texas
University of Virginia Charlottesville Virginia
Seattle Children's Hospital Seattle Washington
Italian Scientific Spine Institute (ISICO) Milan Italy
Starship Child Health Auckland New Zealand

More University of Iowa trials in Italy

Genetics of Charcot Marie Tooth (CMT) - Modifiers of CMT1A, New Causes of CMT2 Recruiting

Other trials for the same condition

Development and Internal Validation of Predicting Models of Idiopathic Scoliosis Natural History and Treatment Outcomes Through the Use of Artificial Intelligence in a Large Clinical Database Active, not recruiting
Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04500041 on ClinicalTrials.gov ↗ ← All trials in Italy