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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04500041




Registration number
NCT04500041
Ethics application status
Date submitted
31/07/2020
Date registered
5/08/2020
Date last updated
28/11/2023

Titles & IDs
Public title
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Scientific title
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Secondary ID [1] 0 0
00000
Universal Trial Number (UTN)
Trial acronym
CVBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scoliosis Idiopathic 0 0
Early-Onset Scoliosis Deformity of Spine 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Casting
Treatment: Devices - Bracing

Active Comparator: Casting - Subjects will be treated with serial casting

Active Comparator: Bracing - Subjects will be treated with full-time orthotics (braces)


Treatment: Surgery: Casting
Use of casts applied using corrective maneuvers

Treatment: Devices: Bracing
Use of full-time spinal orthosis
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Curve Response
Timepoint [1] 0 0
on or before 24 months of treatment
Secondary outcome [1] 0 0
Patient Health-related Quality of Life (HRQOL)
Timepoint [1] 0 0
on or before 24 months of treatment

Eligibility
Key inclusion criteria
Will enroll both patients with scoliosis and 1 of their parents/guardians



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
Minimum age
12 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2025
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hong Kong
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland
Country [28] 0 0
Singapore
State/province [28] 0 0
Singapore
Country [29] 0 0
Turkey
State/province [29] 0 0
Istanbul
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Other
Name
University of Iowa
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Orthopedic Research and Education Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Pediatric Spine Study Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Trial website
https://clinicaltrials.gov/ct2/show/NCT04500041
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart L Weinstein, MD
Address 0 0
University of Iowa
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lori A Dolan, PhD
Address 0 0
Country 0 0
Phone 0 0
319-356-1075
Fax 0 0
Email 0 0
lori-dolan@uiowa.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04500041