ScoliosisNCT02285621
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
A study testing Optimized brace versus conventional Boston brace in people with Scoliosis and Adolescent Idiopathic Scoliosis (AIS), 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. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Optimized brace versus conventional Boston brace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Sep 2021
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10 years or older
- 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 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. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application
- Conditions
- Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Optimized brace versus conventional Boston brace
- Keywords
- Scoliosis, Spine deformity, Brace, 3D
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized brace versus conventional Boston braceOther
Surface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Optimized brace | Experimental | Test group: Patient will receive optimized brace (3D computer assisted design of the brace) Receives: Other: Optimized brace versus conventional Boston brace |
| Standard brace | Active comparator | Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method) Receives: Other: Optimized brace versus conventional Boston 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 radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.
Measured: Baseline, 6 months, 1 year
Secondary outcomes (2)
Change in Scoliosis Research Society questionnaire (SRS-22r) scores
The SRS-22r questionnaire is available from SRS.org. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions. A total score is also available based on all 22 questions.
Measured: Baseline, 6 months, 1 year
Change in surface topography
Four optical scanners are used to capture full trunk images. Subjects are positioned in a standard frame, and reference points marked. Parameters quantifying the external back surface deformity are assessed.
Measured: Baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2019
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 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
- Investigators
- Hubert Labelle, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285621
- Sponsor's protocol ID
- CIHR_259812
- Other IDs
- 259812
- Status last verified
- Nov 2021
- First submitted
- 5 Sep 2014
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cobetto N, Aubin CE, Parent S, Barchi S, Turgeon I, Labelle H. 3D correction of AIS in braces designed using CAD/CAM and FEM: a randomized controlled trial. Scoliosis Spinal Disord. 2017 Jul 23;12:24. doi: 10.1186/s13013-017-0128-9. eCollection 2017.
PubMed 28770254Cobetto N, Aubin CE, Parent S, Clin J, Barchi S, Turgeon I, Labelle H. Effectiveness of braces designed using computer-aided design and manufacturing (CAD/CAM) and finite element simulation compared to CAD/CAM only for the conservative treatment of adolescent idiopathic scoliosis: a prospective randomized controlled trial. Eur Spine J. 2016 Oct;25(10):3056-3064. doi: 10.1007/s00586-016-4434-3. Epub 2016 Feb 9.
PubMed 26861663
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02285621
- Acronym / sponsor ID
- CIHR_259812
- Conditions
- Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis, Spine deformity, Brace, 3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 7 Nov 2014 (estimated)
- 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. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized brace | Experimental | Other: Optimized brace versus conventional Boston braceTest group: Patient will receive optimized brace (3D computer assisted design of the brace) |
| Standard brace | Active comparator | Other: Optimized brace versus conventional Boston braceControl goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method) |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 10 years or older
- 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 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 |
|---|---|---|
| Optimized brace versus conventional Boston braceSurface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient. | Other | Optimized brace, Standard brace |
Primary outcome
Change in Cobb angle
Time frame: Baseline, 6 months, 1 year
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.
2 secondary outcomes
Change in Scoliosis Research Society questionnaire (SRS-22r) scores
Time frame: Baseline, 6 months, 1 year
Change in surface topography
Time frame: Baseline, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 28770254Cobetto N, Aubin CE, Parent S, Barchi S, Turgeon I, Labelle H. 3D correction of AIS in braces designed using CAD/CAM and FEM: a randomized controlled trial. Scoliosis Spinal Disord. 2017 Jul 23;12:24. doi: 10.1186/s13013-017-0128-9. eCollection 2017.
- Derived from this study: PubMed 26861663Cobetto N, Aubin CE, Parent S, Clin J, Barchi S, Turgeon I, Labelle H. Effectiveness of braces designed using computer-aided design and manufacturing (CAD/CAM) and finite element simulation compared to CAD/CAM only for the conservative treatment of adolescent idiopathic scoliosis: a prospective randomized controlled trial. Eur Spine J. 2016 Oct;25(10):3056-3064. doi: 10.1007/s00586-016-4434-3. Epub 2016 Feb 9.
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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.
Hubert Labelle, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized brace versus conventional Boston brace in people with Scoliosis and Adolescent Idiopathic Scoliosis (AIS), 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 5 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: finished, as of the sponsor's last update on 24 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, 6 months, 1 year). 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 NCT02285621, which also lists 2 linked publications.
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 24 Nov 2021.