Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation

St. Justine's Hospital

Status: Unknown

Conditions: Scoliosis; Adolescent Idiopathic Scoliosis

Treatments: Device: Test brace versus control brace: Immediate correction; Device: Test brace versus control brace: Long-term correction

Study type: Interventional

Funder types: Other

Identifiers

NCT04889339

2022-3437

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. Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models. Those models are customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate its clinical application.

Enrollment: 58 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 a 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: Double Blind

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58 participants in 2 patient groups

Test group: Braces designed with growth modulation simulation

Experimental group

Description:

The braces will be designed using a growth modulation method.

Treatment:

Device: Test brace versus control brace: Immediate correction

Device: Test brace versus control brace: Long-term correction

Control group: Conventional method

Active Comparator group

Description:

The braces will be designed by an orthotist without growth modulation simulation.

Treatment:

Device: Test brace versus control brace: Immediate correction

Device: Test brace versus control brace: Long-term correction