Scoliosis
Conditions
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis, AIS, Brace, TLSO
Brief summary
The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.
Interventions
DEVICEThoraco-lumbo-sacral Orthosis
Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed Diagnosis of AIS * Age ≥10, ≤15 years old * Risser 0, 1 or 2 * Primary Cobb angle between 20 and 40 degrees (inclusive) * Apex (of at least one of the primary curves) caudal to T7 * Pre-menarchal OR post-menarchal by ≤1 year * Physical and mental ability to adhere to bracing protocol
Exclusion criteria
* Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature * A history of previous surgical or orthotic treatment * Inability to read and understand Chinese
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Curve progression | Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected | Curve progression to Cobb angle of 50 degrees or more |
Countries
China
Outcome results
None listed