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

NCT ID: NCT06217510

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study with a single group of 15 patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Brace

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

Group Type EXPERIMENTAL

Test Brace

Intervention Type DEVICE

Participants will be fitted with the Test Brace and will wear the brace for 30 minutes.

Interventions

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Test Brace

Participants will be fitted with the Test Brace and will wear the brace for 30 minutes.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Modulate Technologies

UNKNOWN

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hubert Labelle, MD

Orthopeadic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hubert Labelle, MD

Role: CONTACT

1514 345-4931 ext. 4352

Soraya Barchi

Role: CONTACT

1514 345-4931 ext. 4352

Other Identifiers

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MP-21-2024-6669

Identifier Type: -

Identifier Source: org_study_id

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