Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
Primary Purpose
Scoliosis, Adolescent Idiopathic Scoliosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Test brace versus control brace: Immediate correction
Test brace versus control brace: Long-term correction
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring Scoliosis, Spine deformity, Brace, Growth modulation
Eligibility Criteria
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
Sites / Locations
- CHU Sainte-Justine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group: Braces designed with growth modulation simulation
Control group: Conventional method
Arm Description
The braces will be designed using a growth modulation method.
The braces will be designed by an orthotist without growth modulation simulation.
Outcomes
Primary Outcome Measures
Change in Cobb angle
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.
Secondary Outcome Measures
Treatment failure rate
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
Quality of Life (QoL)
The QoL will be measured using the SRS-22r and MOBI questionnaire.
Immediate in-brace Cobb angle
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04889339
Brief Title
Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
Official Title
Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Adolescent Idiopathic Scoliosis
Keywords
Scoliosis, Spine deformity, Brace, Growth modulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group: Braces designed with growth modulation simulation
Arm Type
Experimental
Arm Description
The braces will be designed using a growth modulation method.
Arm Title
Control group: Conventional method
Arm Type
Active Comparator
Arm Description
The braces will be designed by an orthotist without growth modulation simulation.
Intervention Type
Device
Intervention Name(s)
Test brace versus control brace: Immediate correction
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Test brace versus control brace: Long-term correction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cobb angle
Description
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.
Time Frame
Baseline - 2 years
Secondary Outcome Measure Information:
Title
Treatment failure rate
Description
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
Time Frame
Baseline, 2 years
Title
Quality of Life (QoL)
Description
The QoL will be measured using the SRS-22r and MOBI questionnaire.
Time Frame
Baseline, 2 years
Title
Immediate in-brace Cobb angle
Description
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).
Time Frame
5 minutes after brace fitting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert Labelle, MD
Phone
+1514 345-4931
Email
hubert.labelle@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Soraya Barchi
Phone
+1514 345-4931
Ext
4352
Email
soraya.barchi@umontreal.ca
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
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