Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis

Not Applicable

Completed

• Conditions: Scoliosis; Adolescent Idiopathic Scoliosis (AIS)
• Interventions: Other: Optimized brace versus conventional Boston brace

• Registration Number: NCT02285621
• Lead Sponsor: St. Justine's Hospital

Brief Summary

Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-07
• Primary Completion: 2019-09
• Study Completion: 2021-09
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 10 years or older
• AIS diagnosis
• Risser 0-2
• Primary curve angles 20 degrees - 40 degrees
• If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria

• Patients with a pre-existing cardiovascular condition
• Patients with symptom of a neurological disorder
• Patients with any other disorder of the musculoskeletal system affecting the lower limbs,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard brace	Optimized brace versus conventional Boston brace	Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method)
Optimized brace	Optimized brace versus conventional Boston brace	Test group: Patient will receive optimized brace (3D computer assisted design of the brace)

Primary Outcome Measures

Name	Time	Method
Change in Cobb angle	Baseline, 6 months, 1 year	Radiographics will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.

Secondary Outcome Measures

Name	Time	Method
Change in surface topography	Baseline, 6 months, 1 year	Four optical scanners are used to capture full trunk images. Subjects are positioned in a standard frame, and reference points marked. Parameters quantifying the external back surface deformity are assessed.
Change in Scoliosis Research Society questionnaire (SRS-22r) scores	Baseline, 6 months, 1 year	The SRS-22r questionnaire is available from SRS.org. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions. A total score is also available based on all 22 questions.

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada