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Orthopedic Device

Optimized Brace for Adolescent Idiopathic Scoliosis

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
AIS diagnosis
Primary curve angles 20 degrees - 40 degrees
Must not have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up1 year, 2 years
Awards & highlights
No Placebo-Only Group

Study Summary

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

Eligible Conditions
  • Scoliosis
  • Idiopathic Scoliosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your spine has a curve between 20 and 40 degrees.


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

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) - 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
189 Previous Clinical Trials
78,826 Total Patients Enrolled
9 Trials studying Scoliosis
1,948 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

Frequently Asked Questions

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

Is it possible for adults aged eighteen and over to partake in this medical experiment?

"This particular clinical trial specifies that it is seeking individuals aged 10 to 16. Altogether, there are 69 trials for persons under the age of 18 and another 14 studies catering to those above retirement-age."

Answered by AI

Am I eligible to partake in this experiment?

"The research enrolment is open to 58 adolescents affected by scoliosis, ranging in ages from 10-16. Critical eligibility criteria must be met; female patients should either not have gone through menarche or had their last period within 18 months prior to the trial beginning. Furthermore, all participants need to have a Risser 0-2 score."

Answered by AI

Are there vacancies open for participants in this experiment?

"Clinicaltrials.gov confirms that this medical research is actively recruiting. The trial was initially posted on November 15th 2021, and the latest information about it was added to the system on May 4th 2022."

Answered by AI

What is the current participant count of this clinical trial?

"That is correct. Per the information on clinicaltrials.gov, this study commenced recruitment activities on November 15th 2021 and was most recently updated in May 4th 2022. The total number of participants needed is 58 from one single medical facility."

Answered by AI
~19 spots leftby Dec 2024