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NCT06217510 Clinical Trial

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

Adolescent Idiopathic Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06217510
Other study ID # MP-21-2024-6669
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date June 1, 2024

Study information
Verified date January 2024
Source St. Justine's Hospital
Contact Hubert Labelle, MD
Phone 1514 345-4931
Email hubert.labelle@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
St. Justine's Hospital Modulate Technologies

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
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