Adolescent Idiopathic ScoliosisNCT06217510
Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
A study testing Test Brace in people with Adolescent Idiopathic Scoliosis, run by St. Justine's Hospital.
Trial summary
The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Test Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 1 Jun 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnostic of Adolescent Idiopathic Scoliosis
- Risser 0-2
- Cobb Angle between 20 and 40 degrees
- Prescription for a brace
- Able to understand French or English
Who cannot join
- Grade II or higher Spondylolisthesis
- Neuromuscular disease
- Past spinal surgery
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.
Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Test Brace
- Keywords
- Scoliosis, 3D printing, Finite Element Analysis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test BraceDevice
Participants will be fitted with the Test Brace and will wear the brace for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Test Brace | Experimental | A 3D printed brace designed automatically from a digital twin of the participant. Receives: Device: Test Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Questionnaire
Questionnaire given to the participant after the testing period. Data about the experience, impressions about the brace and the comfort will be recorded.
Measured: 30 minutes
Orthotist Adjustment Questionnaire
Questionnaire given to the orthotist after the testing period. Data about the number of adjustment and his experience working with the brace will be recorded.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study with a single group of 15 patients
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Modulate Technologies
- Responsible party
- Principal investigator, Hubert Labelle, MD, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217510
- Sponsor's protocol ID
- MP-21-2024-6669
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
- ClinicalTrials.gov ID
- NCT06217510
- Acronym / sponsor ID
- MP-21-2024-6669
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, 3D printing, Finite Element Analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Modulate Technologies
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Jan 2024 (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.
The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.
Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study with a single group of 15 patients
| Arm | Type | Receives |
|---|---|---|
| Test Brace | Experimental | Device: Test BraceA 3D printed brace designed automatically from a digital twin of the participant. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnostic of Adolescent Idiopathic Scoliosis
- Risser 0-2
- Cobb Angle between 20 and 40 degrees
- Prescription for a brace
- Able to understand French or English
Key exclusion criteria (3 listed)
- Grade II or higher Spondylolisthesis
- Neuromuscular disease
- Past spinal surgery
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 BraceParticipants will be fitted with the Test Brace and will wear the brace for 30 minutes. | Device | Test Brace |
Primary outcome
Participant Questionnaire
Time frame: 30 minutes
Questionnaire given to the participant after the testing period. Data about the experience, impressions about the brace and the comfort will be recorded.
Orthotist Adjustment Questionnaire
Time frame: 30 minutes
Questionnaire given to the orthotist after the testing period. Data about the number of adjustment and his experience working with the brace will be recorded.
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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Test Brace in people with Adolescent Idiopathic Scoliosis, run by St. Justine's Hospital.
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: 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.
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 ext. 4352, hubert.labelle@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Questionnaire (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 22 Jan 2024.