Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by The University of Hong Kong.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Scoliosis Research Society

Information provided by:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00989495

First received: October 1, 2009

Last updated: June 25, 2010

Last verified: June 2010

History of Changes

Purpose

The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).

Condition	Intervention
Adolescent Idiopathic Scoliosis	Device: Brace

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken. [ Time Frame: Baseline and every four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. [ Time Frame: Baseline and every four months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brace - Randomized	Device: Brace Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
No Intervention: Observation - Randomized
Experimental: Brace - preference based	Device: Brace Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
No Intervention: Observation - preference-based

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of AIS
Age ≥10 years
Risser sign 0-2
Cobb's angle 20 deg to <25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to <30 deg

Exclusion Criteria:

History of treatment of AIS
>= 1 year postmenarchal (for girls only)
Physical or mental disability to adhere to bracing
Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
Difficulty to read, understand, and complete the study questionnaires
Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989495

Locations

China
The Duchess of Kent Children's Hospital
Hong Kong, China

Sponsors and Collaborators

The University of Hong Kong

Scoliosis Research Society

More Information

No publications provided

Responsible Party:	Daniel Y.T. Fong, The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00989495 History of Changes
Other Study ID Numbers:	dytfong, HKCTR-819
Study First Received:	October 1, 2009
Last Updated:	June 25, 2010
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:

AIS

Additional relevant MeSH terms:

Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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