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Not yet recruitingNCT06217510Updated Jan 22, 2024

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

An interventional study of Test Brace in Adolescent Idiopathic Scoliosis, sponsored by St. Justine's Hospital. Not yet recruiting. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-01-22.

Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
10 Years to 15 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adolescent Idiopathic Scoliosis

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Keywords

  • Scoliosis
  • 3D printing
  • Finite Element Analysis
03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's planned enrollment of 15 is below the median of 44 across 344 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Grade II or higher Spondylolisthesis
  • Neuromuscular disease
  • Past spinal surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Test Brace

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

    Device: Test Brace

Interventions

  • DeviceTest Brace

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

06

What researchers measure

Primary outcomes

  1. Participant Questionnaire

    Questionnaire given to the participant after the testing period. Data about the experience, impressions about the brace and the comfort will be recorded.

    Time frame: 30 minutes

  2. Orthotist Adjustment Questionnaire

    Questionnaire given to the orthotist after the testing period. Data about the number of adjustment and his experience working with the brace will be recorded.

    Time frame: 30 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06217510
Lead sponsor
St. Justine's Hospital
Collaborators
Modulate Technologies
Responsible party
Hubert Labelle, MD (Orthopeadic Surgeon, St. Justine's Hospital) — Principal investigator
First posted
Jan 22, 2024
Start date
Jan 15, 2024 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Jan 22, 2024

Study contacts

Hubert Labelle, MD
Contact
hubert.labelle@umontreal.ca
1514 345-4931 ext. 4352
Soraya Barchi
Contact
soraya.barchi.hsj@ssss.gouv.qc.ca
1514 345-4931 ext. 4352

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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