NCT01370057

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

5.9 years

First QC Date

May 20, 2011

Last Update Submit

July 18, 2017

Conditions

Scoliosis

Keywords

Adolescent Idiopathic ScoliosisScoliosisAISBraceTLSO

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

Treatment with bracing

Device: Thoraco-lumbo-sacral Orthosis

Control Group

NO INTERVENTION

Watchful waiting without bracing

Interventions

Thoraco-lumbo-sacral OrthosisDEVICE

Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis

Also known as: The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)
Treatment Group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2011

First Posted

June 9, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

CN(1)