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

This study has been terminated.
(Failure of Subject Recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370057
First Posted: June 9, 2011
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CHENG Chun-yiu Jack, Chinese University of Hong Kong
May 20, 2011
June 9, 2011
July 21, 2017
May 2011
April 2017   (Final data collection date for primary outcome measure)
Curve progression [ 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 ]
Curve progression to Cobb angle of 50 degrees or more
Same as current
Complete list of historical versions of study NCT01370057 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Scoliosis
Device: Thoraco-lumbo-sacral Orthosis
Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis
Other Name: The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)
  • Experimental: Treatment Group
    Treatment with bracing
    Intervention: Device: Thoraco-lumbo-sacral Orthosis
  • No Intervention: Control Group
    Watchful waiting without bracing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
April 2017
April 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01370057
BRAIST HK PROTOCOL VER1
No
Not Provided
Not Provided
CHENG Chun-yiu Jack, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Not Provided
Chinese University of Hong Kong
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP