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

St. Justine's Hospital

Status: Completed

Conditions: Scoliosis; Adolescent Idiopathic Scoliosis (AIS)

Treatments: Other: Optimized brace versus conventional Boston brace

Study type: Interventional

Funder types: Other

Identifiers

NCT02285621

259812 (Other Grant/Funding Number)

CIHR_259812

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Optimized brace

Experimental group

Description:

Test group: Patient will receive optimized brace (3D computer assisted design of the brace)

Treatment:

Other: Optimized brace versus conventional Boston brace

Standard brace

Active Comparator group

Description:

Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method)

Treatment:

Other: Optimized brace versus conventional Boston brace