The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)

Chinese University of Hong Kong2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Scoliosis

Interventions

Thoraco-lumbo-sacral OrthosisDEVICE

Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis

Eligibility

Sex: ALLMin age: 10 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hospital

Hong Kong, China

Outcomes

Primary Outcomes

Curve progression

Curve progression to Cobb angle of 50 degrees or more

Time frame: 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

Data from ClinicalTrials.gov

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