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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
  Purpose
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.

Condition Intervention
Scoliosis Device: Thoraco-lumbo-sacral Orthosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by CHENG Chun-yiu Jack, Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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


Enrollment: 2
Study Start Date: May 2011
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
Treatment with bracing
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)
No Intervention: Control Group
Watchful waiting without bracing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370057


Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Responsible Party: CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01370057     History of Changes
Other Study ID Numbers: BRAIST HK PROTOCOL VER1
First Submitted: May 20, 2011
First Posted: June 9, 2011
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by CHENG Chun-yiu Jack, Chinese University of Hong Kong:
Adolescent Idiopathic Scoliosis
Scoliosis
AIS
Brace
TLSO

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases