Casting versus Bracing in the Treatment of Idiopathic Early-Onset Scoliosis
D
Dan Drake, MD
Primary Investigator
Administratively Closed
3 years - 18 years
All
Phase
N/A
220 participants needed
1 Location
Brief description of study
The purpose of this study is to compare treatments for children’s scoliosis. Children who are being seen for spinal curvature treatment at Riley are possible participants.
Detailed description of study
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 the evidence to support informed treatment
decisions.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Scoliosis
-
Age: 3 years - 18 years
-
Gender: All
Inclusion Criteria:
- 1. Diagnosis of idiopathic scoliosis (no congenital anomalies or neurologic abnormalities)2. Child walking independently but ≤3 years of age3. 20°≤ Cobb angle ≤70°4. Rib-vertebral angle difference (RVAD) ≥20 degrees or rib phase II
Exclusion Criteria:
- 1. Not walking independently by 18 mos of age or other signs/symptoms of developmental delay2. Previous treatment for IEOSInability to finance treatment thru private/public insurance or self-pay
Updated on
18 Sep 2024.
Study ID: 2008487906, ORTHO-UI-CVBT
