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Casting vs Bracing for Idiopathic Early-Onset Scoliosis (CVBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500041
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : November 8, 2021
Sponsor:
Collaborators:
Orthopedic Research and Education Foundation
Pediatric Spine Study Group
Information provided by (Responsible Party):
Stuart L. Weinstein, MD, University of Iowa

Study Description
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Brief Summary:
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Early-Onset Scoliosis Deformity of Spine Procedure: Casting Device: Bracing Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment (casting or bracing) via randomized assignment OR based on family preference
Masking: Single (Outcomes Assessor)
Masking Description: Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.
Primary Purpose: Treatment
Official Title: Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Casting
Subjects will be treated with serial casting
 Procedure: Casting
Use of casts applied using corrective maneuvers
Active Comparator: Bracing
Subjects will be treated with full-time orthotics (braces)
 Device: Bracing
Use of full-time spinal orthosis


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Patient Health-related Quality of Life (HRQOL) [ Time Frame: on or before 24 months of treatment ]
    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.


Other Outcome Measures:
  1. Parent and Family Functioning [ Time Frame: on or before 24 months of treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500041


Contacts
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Contact: Lori A Dolan, PhD 319-356-1075 lori-dolan@uiowa.edu

Locations
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Sponsors and Collaborators
University of Iowa
Orthopedic Research and Education Foundation
Pediatric Spine Study Group
Investigators
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Principal Investigator: Stuart L Weinstein, MD University of Iowa
More Information
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Responsible Party: Stuart L. Weinstein, MD, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04500041    
Other Study ID Numbers: 00000
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All study data (assessments and images) will reside in the Pediatric Spine Registry.
Supporting Materials: Study Protocol
Time Frame: after our planned analyses and publications are completed
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stuart L. Weinstein, MD, University of Iowa:
Cast
Brace
Spinal Orthosis
Spinal Orthotic
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases