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

Not Applicable

Terminated

• Conditions: Scoliosis
• Interventions: Device: Thoraco-lumbo-sacral Orthosis

• Registration Number: NCT01370057
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Thoraco-lumbo-sacral Orthosis	Treatment with bracing

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China