Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis

St. Justine's Hospital

Status: Active, not recruiting

Conditions: Idiopathic Scoliosis; Scoliosis

Treatments: Device: Long-term bracing: Optimized Brace; Device: Long-term bracing: Conventional Brace; Device: Immediate in-brace correction: Conventional Brace; Device: Immediate in-brace correction: Optimized Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT05001568

20223437

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 optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.

Enrollment: 58 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
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Optimized Providence brace

Experimental group

Description:

The braces will be designed using optimization and finite element analysis.

Treatment:

Device: Long-term bracing: Optimized Brace

Device: Immediate in-brace correction: Optimized Brace

Device: Immediate in-brace correction: Conventional Brace

Conventional Providence brace

Active Comparator group

Description:

The braces will be designed by an orthotist using the conventional design method.

Treatment:

Device: Long-term bracing: Conventional Brace

Device: Immediate in-brace correction: Optimized Brace

Device: Immediate in-brace correction: Conventional Brace