Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)

St. Justine's Hospital

Status: Not yet enrolling

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Device: Test Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT06217510

MP-21-2024-6669

Details and patient eligibility

About

The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.

Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.

Enrollment: 15 estimated patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnostic of Adolescent Idiopathic Scoliosis
• Risser 0-2
• Cobb Angle between 20 and 40 degrees
• Prescription for a brace
• Able to understand French or English

Exclusion criteria

• Grade II or higher Spondylolisthesis
• Neuromuscular disease
• Past spinal surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Test Brace

Experimental group

Description:

A 3D printed brace designed automatically from a digital twin of the participant.

Treatment:

Device: Test Brace