Casting vs Bracing for Idiopathic Early-Onset Scoliosis

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    440
  • sponsor
    University of Iowa
Updated on 15 November 2021

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.

Details
Condition Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine
Treatment Casting, Bracing
Clinical Study IdentifierNCT04500041
SponsorUniversity of Iowa
Last Modified on15 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient Inclusion
Diagnosis of idiopathic early-onset scoliosis
Child standing independently but not older than 3 years of age
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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