- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889339
Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
May 11, 2021 updated by: Hubert Labelle, MD, St. Justine's Hospital
Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt.
Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models.
Those models are customized to each patient.
In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate its clinical application.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hubert Labelle, MD
- Phone Number: +1514 345-4931
- Email: hubert.labelle@umontreal.ca
Study Contact Backup
- Name: Soraya Barchi
- Phone Number: 4352 +1514 345-4931
- Email: soraya.barchi@umontreal.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C5
- CHU Sainte-Justine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- AIS diagnosis
- Risser 0-2
- Primary curve angles 20 degrees - 40 degrees
- If female, either premenarchal or less than 18 months postmenarchal.
Exclusion Criteria:
- Patients with a pre-existing cardiovascular condition
- Patients with a symptom of a neurological disorder
- Patients with any other disorder of the musculoskeletal system affecting the lower limbs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test group: Braces designed with growth modulation simulation
The braces will be designed using a growth modulation method.
|
The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace.
The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system.
Each patient will try both the control and the test brace.
Radiographic and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces.
The SRS-22r will be collected.
The study protocol requires no additional visits beyond the standard of care.
There will be one additional radiograph compared to the standard of care.
After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years.
There will be follow-up visits, between 6 months and 1 year depending on the patient growth.
The brace will be renewed using the same procedure to adapt to the patient's growth.
The study protocol requires no additional visits beyond the standard of care.
There will be no additional radiograph compared to the standard of care.
Compliance monitors are installed in each brace.
|
Active Comparator: Control group: Conventional method
The braces will be designed by an orthotist without growth modulation simulation.
|
The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace.
The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system.
Each patient will try both the control and the test brace.
Radiographic and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces.
The SRS-22r will be collected.
The study protocol requires no additional visits beyond the standard of care.
There will be one additional radiograph compared to the standard of care.
After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years.
There will be follow-up visits, between 6 months and 1 year depending on the patient growth.
The brace will be renewed using the same procedure to adapt to the patient's growth.
The study protocol requires no additional visits beyond the standard of care.
There will be no additional radiograph compared to the standard of care.
Compliance monitors are installed in each brace.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cobb angle
Time Frame: Baseline - 2 years
|
Radiographics will be gathered and analyzed to observe changes between time points.
All radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.
|
Baseline - 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment failure rate
Time Frame: Baseline, 2 years
|
Treatment failure is defined as having a Cobb angle progress by more than 5 degrees compared to the baseline measurement or exceeding a value of 45 degrees
|
Baseline, 2 years
|
Quality of Life (QoL)
Time Frame: Baseline, 2 years
|
The QoL will be measured using the SRS-22r and MOBI questionnaire.
|
Baseline, 2 years
|
Immediate in-brace Cobb angle
Time Frame: 5 minutes after brace fitting
|
Radiographics will be gathered and analyzed to observe changes between the control and test braces.
All radiographs will be taken with an low-dose biplane radiographic system (EOS).
|
5 minutes after brace fitting
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
January 1, 2024
Study Registration Dates
First Submitted
May 3, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 11, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-3437
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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