Language: BG BG
← Back to results
Active (not recruiting) Not applicable NCT04500041

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

No applicable phase (e.g. observational)
Conditions: Scoliosis Idiopathic Early-Onset Scoliosis Deformity of Spine

Sponsor: University of Iowa

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 3
Italy (1)
Italian Scientific Spine Institute (ISICO)
Milan
New Zealand (1)
Starship Child Health
Auckland
United States (1)
Arkansas Children's Hospital
Little Rock , Arkansas
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Months
Maximum age
36 Months
Healthy volunteers
No
Start date
09.02.2021
Completion date
30.09.2026
Registry ID
NCT04500041
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.