ScoliosisNCT05001568
Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis
A study testing Immediate in-brace correction: Conventional Brace, Immediate in-brace correction: Optimized Brace and Long-term bracing: Conventional Brace in people with Scoliosis and 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 optimizing for the immediate in-brace correction. The model is customized to each patient. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Scoliosis, Idiopathic Scoliosis
- What is being tested?
- Immediate in-brace correction: Conventional Brace, Immediate in-brace correction: Optimized Brace and Long-term bracing: Conventional Brace
- 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
- 15 Nov 2021to Jan 2025
- 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
- Pregnancy
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 optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.
- Conditions
- Scoliosis, Idiopathic Scoliosis
- Being tested
- Immediate in-brace correction: Conventional Brace, Immediate in-brace correction: Optimized Brace, Long-term bracing: Conventional Brace, Long-term bracing: Optimized Brace
- Keywords
- Scoliosis, Spine deformity, Nighttime brace, Optimization
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate in-brace correction: Conventional BraceDevice
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 (supine position) 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.
Immediate in-brace correction: Optimized BraceDevice
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 (supine position) 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.
Long-term bracing: Conventional BraceDevice
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.
Long-term bracing: Optimized BraceDevice
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 |
|---|---|---|
| Optimized Providence brace | Experimental | The braces will be designed using optimization and finite element analysis. Receives: Device: Immediate in-brace correction: Conventional Brace; Device: Immediate in-brace correction: Optimized Brace; Device: Long-term bracing: Optimized Brace |
| Conventional Providence brace | Active comparator | The braces will be designed by an orthotist using the conventional design method. Receives: Device: Immediate in-brace correction: Conventional Brace; Device: Immediate in-brace correction: Optimized Brace; Device: Long-term bracing: Conventional Brace |
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 out-of-brace radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.
Measured: Baseline, 1 year, 2 years
Secondary outcomes (4)
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, 1 year, 2 years
Quality of Life (QoL) - SRS-22r
The QoL will be measured using the Scoliosis Reasearch Society (SRS)-22r.
Measured: Baseline, 1 year, 2 years
Quality of Life (QoL) - MOBI
The QoL will be measured using the My Orthopedic Brace Inventory (MOBI) questionnaire.
Measured: 1 year, 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 the patient in a supine position.
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 posted12 Aug 2021
- Study start15 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (actual)
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
- NCT05001568
- Sponsor's protocol ID
- 20223437
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2021
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coulombe M, Guy A, Barchi S, Labelle H, Aubin CE. Optimized braces for the treatment of adolescent idiopathic scoliosis: A study protocol of a prospective randomised controlled trial. PLoS One. 2024 Feb 7;19(2):e0292069. doi: 10.1371/journal.pone.0292069. eCollection 2024.
PubMed 38324512
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05001568
- Acronym / sponsor ID
- 20223437
- Conditions
- Scoliosis, Idiopathic Scoliosis
- Keywords
- Scoliosis, Spine deformity, Nighttime brace, Optimization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 12 Aug 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 optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's 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 |
|---|---|---|
| Optimized Providence brace | Experimental | Device: Immediate in-brace correction: Conventional Brace, Device: Immediate in-brace correction: Optimized Brace, Device: Long-term bracing: Optimized BraceThe braces will be designed using optimization and finite element analysis. |
| Conventional Providence brace | Active comparator | Device: Immediate in-brace correction: Conventional Brace, Device: Immediate in-brace correction: Optimized Brace, Device: Long-term bracing: Conventional BraceThe braces will be designed by an orthotist using the conventional design method. |
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 (4 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
- Pregnancy
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 |
|---|---|---|
| Immediate in-brace correction: Conventional BraceThe 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 (supine position) 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 | Conventional Providence brace, Optimized Providence brace |
| Immediate in-brace correction: Optimized BraceThe 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 (supine position) 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 | Conventional Providence brace, Optimized Providence brace |
| Long-term bracing: Conventional BraceAfter 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 | Conventional Providence brace |
| Long-term bracing: Optimized BraceAfter 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 | Optimized Providence brace |
Primary outcome
Change in Cobb angle
Time frame: Baseline, 1 year, 2 years
Radiographics will be gathered and analyzed to observe changes between time points. All out-of-brace radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.
4 secondary outcomes
Treatment failure rate
Time frame: Baseline, 1 year, 2 years
Quality of Life (QoL) - SRS-22r
Time frame: Baseline, 1 year, 2 years
Quality of Life (QoL) - MOBI
Time frame: 1 year, 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 22 Jan 2024.
- Derived from this study: PubMed 38324512Coulombe M, Guy A, Barchi S, Labelle H, Aubin CE. Optimized braces for the treatment of adolescent idiopathic scoliosis: A study protocol of a prospective randomised controlled trial. PLoS One. 2024 Feb 7;19(2):e0292069. doi: 10.1371/journal.pone.0292069. eCollection 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate in-brace correction: Conventional Brace, Immediate in-brace correction: Optimized Brace and Long-term bracing: Conventional Brace in people with Scoliosis and 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 4 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 22 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cobb angle (time frame: Baseline, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05001568, which also lists 1 linked publication.
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 22 Jan 2024.