Summary

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Conditions

  • Scoliosis Idiopathic
  • Early-Onset Scoliosis Deformity of Spine

Recruitment Status

ACTIVE_NOT_RECRUITING

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.

Eligibility 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

Phase

NA

Gender

ALL

Min Age

12 Months

Max Age

36 Months

Download Date

2024-12-16

Principal Investigator

Primary Investigator

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Contact Info
Lauren Hutchinson
lauren.hutchinson@childrens.harvard.edu
617-919-1632

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Intervention

Intervention Type

PROCEDURE

DEVICE

Intervention Name

Casting

Bracing

Contact

For more information and to contact the study team:

Casting Vs Bracing for Idiopathic Early-Onset Scoliosis NCT04500041 Lauren Hutchinson lauren.hutchinson@childrens.harvard.edu 617-919-1632