Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Scoliosis Idiopathic Clinical Trial

— CVBT  

Official title:

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500041
• Other study ID #: 00000
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: January 30, 2025

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: Lori A Dolan, PhD
• Phone: 319-356-1075
• Email: lori-dolan[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: January 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Early-Onset Scoliosis Deformity of Spine
• Scoliosis
• Scoliosis Idiopathic

Intervention

Procedure:
• Casting
Use of casts applied using corrective maneuvers

Device:
• Bracing
Use of full-time spinal orthosis

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Hong Kong	University of Hong Kong	Hong Kong
Italy	Italian Scientific Spine Institute (ISICO)	Milano
New Zealand	Starship Child Health	Auckland
Singapore	National University Hospital	Singapore
Turkey	Acibadem Maslak Hospital	Istanbul
United Kingdom	Royal Orthopaedic Hospital	Birmingham
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins	Baltimore	Maryland
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Shriners Hospitals for Children - Chicago	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Campbell Clinic/Le Bonheur Children's Hospital	Germantown	Tennessee
United States	Texas Children's Hospital	Houston	Texas
United States	Riley's Hospital for Children at IU Healthcare	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Morgan Stanley Children's Hospital	New York	New York
United States	Children's Hospital of Pennsylvania	Philadelphia	Pennsylvania
United States	Shriners Hospitals for Children - Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Doernbecher Children's Hospital / OHSU	Portland	Oregon
United States	Shriners Hospitals for Children - Portland	Portland	Oregon
United States	Golisano Children's Hospital/University of Rochester	Rochester	New York
United States	St. Louis Children's Hospital/Washington University	Saint Louis	Missouri
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	Seattle Children's Hospital	Seattle	Washington
United States	Nemours/Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	Orthopedic Research and Education Foundation, Pediatric Spine Study Group

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  Italy,  New Zealand,  Singapore,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent and Family Functioning	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.	on or before 24 months of treatment
Primary	Curve Response	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	on or before 24 months of treatment
Secondary	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.	on or before 24 months of treatment