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Register:	ClinicalTrials.gov
Last refreshed on:	29 April 2024
Main ID:	NCT02434003
Date of registration:	18/04/2015
Prospective Registration:	No
Primary sponsor:	St. Justine's Hospital
Public title:	Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
Scientific title:	Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
Date of first enrolment:	May 2014
Target sample size:	1200
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02434003
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Canada	France	Hong Kong	Japan	Singapore	United States

Contacts

Name:	Stefan Parent, MD, PhD
Address:
Telephone:
Email:	stefan.parent@umontreal.ca
Affiliation:

Name:	Stefan Parent, MD, PhD
Address:
Telephone:
Email:
Affiliation:	St. Justine's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic Scoliosis (as diagnosed by the surgeon)

- Patients above 10 year old at the time of recruitment

- Spina bifida occulta with no neurological signs and otherwise normal

- Curves ranging between 11º and 40º of Cobb angle measurement and

- Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the
spine.

- All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will
be included in the study.

Exclusion Criteria:

- Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis
initiation,

- Congenital scoliosis,

- MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation)

- Syndromic scoliosis (associated with Marfan's or other genetic syndromes),

- Neuromuscular scoliosis,

- Developmental delay

- Spinal asymmetry

- Symptomatic spondylolisthesis

- Leg length discrepancy longer than 1 cm.

- Unable or unwilling to firmly commit to returning for required follow-up visits

Age minimum: 10 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Scoliosis

Intervention(s)

Primary Outcome(s)

Change in scoliosis severity based on the 3D reconstruction of the spine at the initial visit and follow ups in a large multicenter prospective study [Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months]

Secondary Outcome(s)

Secondary ID(s)

3896

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Queen Mary Hospital, Hong Kong

Alfred I. duPont Hospital for Children

Rady Children's Hospital, San Diego

National University of Singapore

Hopital Universitaire Robert-Debre

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

The Meijo Hospital, Nagoya, Japan

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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