search
Back to results

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

Primary Purpose

Scoliosis

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thoraco-lumbo-sacral Orthosis
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, Scoliosis, AIS, Brace, TLSO

Eligibility Criteria

10 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Treatment with bracing

Watchful waiting without bracing

Outcomes

Primary Outcome Measures

Curve progression
Curve progression to Cobb angle of 50 degrees or more

Secondary Outcome Measures

Full Information

First Posted
May 20, 2011
Last Updated
July 18, 2017
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01370057
Brief Title
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
Official Title
The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Failure of Subject Recruitment
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis, AIS, Brace, TLSO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment with bracing
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Watchful waiting without bracing
Intervention Type
Device
Intervention Name(s)
Thoraco-lumbo-sacral Orthosis
Other Intervention Name(s)
The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)
Intervention Description
Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis
Primary Outcome Measure Information:
Title
Curve progression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs