ScoliosisNCT04889339
Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
A study of Scoliosis and Adolescent Idiopathic Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Scoliosis, Adolescent Idiopathic Scoliosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2021to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- AIS diagnosis
- Risser 0-2
- Primary curve angles 20 degrees - 40 degrees
- If female, either premenarchal or less than 18 months postmenarchal.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Scoliosis, Adolescent Idiopathic Scoliosis
- Being tested
- Test brace versus control brace: Immediate correction, Test brace versus control brace: Long-term correction
- Keywords
- Scoliosis, Spine deformity, Brace, Growth modulation
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test brace versus control brace: Immediate correctionDevice
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.
Test brace versus control brace: Long-term correctionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group: Braces designed with growth modulation simulation | Experimental | The braces will be designed using a growth modulation method. Receives: Device: Test brace versus control brace: Immediate correction; Device: Test brace versus control brace: Long-term correction |
| Control group: Conventional method | Active comparator | The braces will be designed by an orthotist without growth modulation simulation. Receives: Device: Test brace versus control brace: Immediate correction; Device: Test brace versus control brace: Long-term correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 2 years
Secondary outcomes (3)
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
Measured: Baseline, 2 years
Quality of Life (QoL)
The QoL will be measured using the SRS-22r and MOBI questionnaire.
Measured: Baseline, 2 years
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).
Measured: 5 minutes after brace fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study startJun 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hubert Labelle, MD, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889339
- Sponsor's protocol ID
- 2022-3437
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
- ClinicalTrials.gov ID
- NCT04889339
- Acronym / sponsor ID
- 2022-3437
- Conditions
- Scoliosis, Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Spine deformity, Brace, Growth modulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test group: Braces designed with growth modulation simulation | Experimental | Device: Test brace versus control brace: Immediate correction, Device: Test brace versus control brace: Long-term correctionThe braces will be designed using a growth modulation method. |
| Control group: Conventional method | Active comparator | Device: Test brace versus control brace: Immediate correction, Device: Test brace versus control brace: Long-term correctionThe braces will be designed by an orthotist without growth modulation simulation. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- AIS diagnosis
- Risser 0-2
- Primary curve angles 20 degrees - 40 degrees
- If female, either premenarchal or less than 18 months postmenarchal.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test brace versus control brace: Immediate correctionThe 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. | Device | Control group: Conventional method, Test group: Braces designed with growth modulation simulation |
| Test brace versus control brace: Long-term correctionAfter 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. | Device | Control group: Conventional method, Test group: Braces designed with growth modulation simulation |
Primary outcome
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.
3 secondary outcomes
Treatment failure rate
Time frame: Baseline, 2 years
Quality of Life (QoL)
Time frame: Baseline, 2 years
Immediate in-brace Cobb angle
Time frame: 5 minutes after brace fitting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Scoliosis and Adolescent Idiopathic Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hubert Labelle, MD (+1514 345-4931, hubert.labelle@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cobb angle (time frame: Baseline - 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.