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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cobb angle

Secondary outcome measures

Immediate in-brace Cobb angle

Quality of Life (QoL)

Treatment failure rate

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,971 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this medical trial limited to individuals aged 65 and over?

"Participants in this trial must be between 10 and 16 years old."

Answered by AI

Is enrolment currently open for this trial?

"A review of clinicaltrials.gov reveals that this particular trial is no longer recruiting new patients, having been posted on June 1st 2021 and last updated May 11th 2021. However, there are 77 other studies presently open for participant enrolment."

Answered by AI

What criteria must prospective participants satisfy in order to participate in this trial?

"This clinical trial is intent on recruiting 58 minors aged 10 to 16 who have been diagnosed with scoliosis. Additionally, the research team seeks participants that are either pre-menarcheal or within 18 months post-menarcheal (if female). The primary curve angles should measure between 20 and 40 degrees while Risser classification must be 0 to 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation

Hubert Labelle, MD 2021. "Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04889339.

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