The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the T... | NCT01370057

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

NCT01370057

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Jul 21, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Scoliosis

Interventions

Thoraco-lumbo-sacral Orthosis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure of Subject Recruitment

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

May 20, 2011

First Submission Date that Met QC Criteria

Jun 8, 2011

First Posted Date

Jun 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2017

Last Update Posted Date

Jul 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	Treatment with bracing	Device: Thoraco-lumbo-sacral Orthosis
Control Group	No Intervention	Watchful waiting without bracing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoraco-lumbo-sacral Orthosis	Device	Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Curve progression	Curve progression to Cobb angle of 50 degrees or more	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided