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

This study is currently recruiting participants.
Verified May 2011 by Chinese University of Hong Kong
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01370057
First received: May 20, 2011
Last updated: June 8, 2011
Last verified: May 2011
History of Changes
  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 Phase
Scoliosis
 Device: Thoraco-lumbo-sacral Orthosis
Other: Watchful waiting
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    Curve progression to Cobb angle of 50 degrees or more


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: April 2017
Estimated 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
 Other: Watchful waiting
Monitoring of spinal deformity without bracing

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370057

Contacts
Contact: Tsz Ping Lam, MB.,BS 852-26323309 tplam@ort.cuhk.edu.hk

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Tsz Ping Lam, MB.,BS     852-26323309     tplam@ort.cuhk.edu.hk    
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Jack Chun Yiu CHENG, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01370057     History of Changes
Other Study ID Numbers: BRAIST HK PROTOCOL VER1
Study First Received: May 20, 2011
Last Updated: June 8, 2011
Health Authority: Hong Kong: Department of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013