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

Scoliosis Clinical Trial

Official title:

The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01370057
• Other study ID #: BRAIST HK PROTOCOL VER1
• Status: Terminated
• Phase: N/A
• First received: May 20, 2011
• Last updated: July 18, 2017
• Start date: May 2011
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Thoraco-lumbo-sacral Orthosis
Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Curve progression	Curve progression to Cobb angle of 50 degrees or more	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