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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04500041
Ethics application status
Date submitted
31/07/2020
Date registered
5/08/2020

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
202003169
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
Active, not 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
30/01/2026
Actual
Sample size
Target
Accrual to date
Final
71
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
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All study data (assessments and images) will reside in the Pediatric Spine Registry.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
after our planned analyses and publications are completed
Available to whom?
Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04500041