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
NA
Gender
ALL
Min Age
12 Months
Max Age
36 Months
Download Date
2023-11-28
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: