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Orthopedic Brace

Orthopedic Brace for Adolescent Idiopathic Scoliosis

N/A
Waitlist Available
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new, customized brace treatment for adolescent idiopathic scoliosis, which affects 3-4% of the population.

Who is the study for?
This trial is for young people with Adolescent Idiopathic Scoliosis, having primary curve angles between 20-40 degrees. It's suitable for girls who are premenarchal or less than 18 months postmenarchal and have a Risser sign of 0-2. Those with cardiovascular issues, other musculoskeletal disorders affecting the legs, or neurological symptoms can't join.
What is being tested?
The study tests a new orthopedic brace designed using growth modulation simulations tailored to each patient against a standard brace. The goal is to see if this custom approach better corrects spine curvature immediately and in the long term.
What are the potential side effects?
While not specified here, typical side effects from wearing braces may include discomfort, skin irritation, and restricted movement. Customized braces aim to minimize these by fitting better.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Cobb angle
Secondary study objectives
Immediate in-brace Cobb angle
Quality of Life (QoL)
Treatment failure rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test group: Braces designed with growth modulation simulationExperimental Treatment2 Interventions
The braces will be designed using a growth modulation method.
Group II: Control group: Conventional methodActive Control2 Interventions
The braces will be designed by an orthotist without growth modulation simulation.

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
85,782 Total Patients Enrolled

Media Library

Control brace (Orthopedic Brace) Clinical Trial Eligibility Overview. Trial Name: NCT04889339 — N/A
Adolescent Idiopathic Scoliosis Research Study Groups: Test group: Braces designed with growth modulation simulation, Control group: Conventional method
Adolescent Idiopathic Scoliosis Clinical Trial 2023: Control brace Highlights & Side Effects. Trial Name: NCT04889339 — N/A
Control brace (Orthopedic Brace) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889339 — N/A
~13 spots leftby Nov 2025
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