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Orthopedic Device

Optimized Nighttime Brace for 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
If female, either premenarchal or less than 18 months postmenarchal.
AIS diagnosis
Must not have
Patients with a symptom of a neurological disorder
Patients with any other disorder of the musculoskeletal system affecting the lower limbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new method for designing braces to correct adolescent idiopathic scoliosis, which affects 3-4% of Canadians.

Who is the study for?
This trial is for young people with Adolescent Idiopathic Scoliosis (AIS) who have a primary curve of their spine between 20-40 degrees. Girls should be early in puberty, and all participants must not have advanced bone maturity (Risser 0-2). It's not open to those with cardiovascular or neurological disorders, other musculoskeletal issues affecting the legs, or if pregnant.
What is being tested?
The study tests two types of braces for scoliosis: a conventional brace and an optimized brace designed using a new method tailored to each patient. The effectiveness of immediate correction by both braces and their long-term use will be compared.
What are the potential side effects?
While the trial does not list specific side effects, wearing braces can typically cause discomfort, skin irritation, and potential impact on self-image due to body changes. Long-term bracing might also affect muscle development.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a female who has not started menstruating or started less than 18 months ago.
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I have been diagnosed with AIS.
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My skeletal maturity is at a Risser stage of 0 to 2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing symptoms of a neurological disorder.
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I have a condition affecting my legs.
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I have a heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 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) - MOBI
Quality of Life (QoL) - SRS-22r
+1 more

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: Optimized Providence braceExperimental Treatment3 Interventions
The braces will be designed using optimization and finite element analysis.
Group II: Conventional Providence braceActive Control3 Interventions
The braces will be designed by an orthotist using the conventional design method.

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
85,782 Total Patients Enrolled
10 Trials studying Scoliosis
1,963 Patients Enrolled for Scoliosis

Media Library

Conventional Brace (Orthopedic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05001568 — N/A
Scoliosis Research Study Groups: Optimized Providence brace, Conventional Providence brace
Scoliosis Clinical Trial 2023: Conventional Brace Highlights & Side Effects. Trial Name: NCT05001568 — N/A
~0 spots leftby Dec 2024
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