Scoliosis IdiopathicCVBTNCT04500041
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
A study testing Casting and Bracing in people with Scoliosis Idiopathic and Early-Onset Scoliosis Deformity of Spine, run by University of Iowa at 26 sites in 3 countries.
Trial summary
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine
- What is being tested?
- Casting and Bracing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 9 Feb 2021to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- Parent Inclusion
- Parent or guardian of the minor subject
- Consent to participate
- Able to complete surveys
Who cannot join
- 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
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States24 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins
Baltimore, Maryland, 21287
Children's Hospital of Boston
Boston, Massachusetts, 02115
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
University of Virginia
Charlottesville, Virginia, 22903
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Shriners Hospitals for Children - Chicago
Chicago, Illinois, 60707
Duke University Medical Center
Durham, North Carolina, 27710
Texas Children's Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Shriners Hospitals for Children - Philadelphia
Philadelphia, Pennsylvania, 19140
Doernbecher Children's Hospital / OHSU
Portland, Oregon, 97239
Shriners Hospitals for Children - Portland
Portland, Oregon, 97239
Golisano Children's Hospital/University of Rochester
Rochester, New York, 14642
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital/Washington University
St Louis, Missouri, 63110
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Read the detailed 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.
- Being tested
- Casting, Bracing
- Keywords
- Cast, Brace, Spinal Orthosis, Spinal Orthotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CastingProcedure or surgery
Use of casts applied using corrective maneuvers
BracingDevice
Use of full-time spinal orthosis
| Study group | Role | What they receive |
|---|---|---|
| Casting | Active comparator | Subjects will be treated with serial casting Receives: Procedure: Casting |
| Bracing | Active comparator | Subjects will be treated with full-time orthotics (braces) Receives: Device: Bracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on or before 24 months of treatment
Secondary outcomes (1)
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.
Measured: on or before 24 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start9 Feb 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment (casting or bracing) via randomized assignment OR based on family preference
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Pediatric Spine Study Group
- Responsible party
- Principal investigator, Stuart L. Weinstein, MD, University of Iowa
- Investigators
- Stuart L Weinstein, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500041
- Sponsor's protocol ID
- 202003169
- Acronym
- CVBT
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2020
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All study data (assessments and images) will reside in the Pediatric Spine Registry.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Casting vs Bracing for Idiopathic Early-Onset Scoliosis
- ClinicalTrials.gov ID
- NCT04500041
- Acronym / sponsor ID
- CVBT / 202003169
- Keywords
- Cast, Brace, Spinal Orthosis, Spinal Orthotic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Pediatric Spine Study Group
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment (casting or bracing) via randomized assignment OR based on family preference
| Arm | Type | Receives |
|---|---|---|
| Casting | Active comparator | Procedure: CastingSubjects will be treated with serial casting |
| Bracing | Active comparator | Device: BracingSubjects will be treated with full-time orthotics (braces) |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CastingUse of casts applied using corrective maneuvers | Procedure or surgery | Casting |
| BracingUse of full-time spinal orthosis | Device | Bracing |
Primary outcome
Curve Response
Time frame: 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
1 secondary outcome
Patient Health-related Quality of Life (HRQOL)
Time frame: on or before 24 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. All study data (assessments and images) will reside in the Pediatric Spine Registry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart L Weinstein, MD principal investigator
University of Iowa
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casting and Bracing in people with Scoliosis Idiopathic and Early-Onset Scoliosis Deformity of Spine, run by University of Iowa at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Italy, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curve Response (time frame: on or before 24 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.