NCT06217510

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 8, 2024

Last Update Submit

January 18, 2024

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis3D printingFinite Element Analysis

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 minutes

  • 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.

    30 minutes

Study Arms (1)

Test Brace

EXPERIMENTAL

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

Device: Test Brace

Interventions

Test BraceDEVICE

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

Test Brace

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Hubert Labelle, MD

CONTACT

1514 345-4931hubert.labelle@umontreal.ca

Soraya Barchi

CONTACT

1514 345-4931soraya.barchi.hsj@ssss.gouv.qc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study with a single group of 15 patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopeadic Surgeon

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 22, 2024

Study Start

January 15, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share