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
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
Intervention
Intervention Type
Intervention Name
Procedure
Casting
Device
Bracing
Phase
Not Applicable
Gender
All
Min Age
12 Months
Max Age
36 Months
Download Date
November 28, 2023
Principal Investigator
Timothy Hresko, MD
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
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.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: