Juvenile Idiopathic ScoliosisBRAIVE IDENCT04929678
Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
A study testing Braive™ Growth Modulation System (Braive™ GMS) in people with Juvenile Idiopathic Scoliosis and Adolescent Idiopathic Scoliosis, run by Medtronic Spinal and Biologics at 4 sites in 3 countries.
Trial summary
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
- What is being tested?
- Braive™ Growth Modulation System (Braive™ GMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 12 Aug 2021to 14 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A subject must meet all of the following inclusion criteria to participate in this study:
- Has a diagnosis of juvenile or adolescent idiopathic scoliosis
- Is skeletally immature with a Sanders Score of ≥2 to ≤5
- Has failed conservative care as per investigator's assessment
- Has a main thoracic Cobb angle between 30 and 60 degrees
- Has a Lenke Classification of 1A, 1B, or 1C
- Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative
- Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by Parent/legal guardian and/or patient/participant per local requirement.
Who cannot join
- A subject will be excluded from participating in this study for any of the following reasons:
- Has undergone previous spinal fusion procedure(s) at the affected levels
- Is pregnant or plans to become pregnant within the first 24-months of the study
- Has a curve that requires instrumentation below L1
- Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
- Has any type of non-idiopathic scoliosis
Show all 19Show fewer
- Has a left-sided curve
- Has an associated syndrome
- Has a history of malignant hyperthermia
- Has an active or significant risk of infection (immunocompromised)
- Has inadequate tissue coverage over the operative site as per investigator's assessment
- Has a suspected or documented allergy or intolerance to implant materials
- Has a major psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference)
- Is a ward of the court/state
- Has had prior ipsilateral or contralateral chest surgery
- Has severe chronic lung disease (e.g., asthma, bronchiectasis)
- Has poor bone quality, as determined by the investigator, that may limit anterior fixation
- Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Canada2 sites
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
United Kingdom1 site
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
Newcastle upon Tyne, NE7 7DN
About this study
Official title: A Prospective, Multi-Center Study of the Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed With Juvenile or Adolescent Idiopathic Scoliosis
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
- Being tested
- Braive™ Growth Modulation System (Braive™ GMS)
- Keywords
- Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Progressive Scoliosis, BRAIVE, Anterior Vertebral Body Tethering, AVBT, Growth modulation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Braive™ Growth Modulation System (Braive™ GMS)Device
The Braive™ GMS is designed as a growth-modulation, non-fusion technique, which utilizes patients' remaining growth potential to limit further progression of the curve, to provide correction of the thoracic spine, and allow continued growth while maintaining mobility.
The system consists of the following components: Braid, Fixed Angle Screws (FAS), Plate, and Break-Off Set Screw.
| Study group | Role | What they receive |
|---|---|---|
| Braive™ Growth Modulation System (Braive™ GMS) | Experimental | Not described Receives: Device: Braive™ Growth Modulation System (Braive™ GMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Device-related Adverse Events up to 24 Months
Device related adverse events are any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the investigational medical device whether anticipated or unanticipated.
Summary will be based on both Investigators and Medtronic relatedness assessment.
Measured: Implanted surgery to 24 months
Secondary outcomes (15)
Assessment of Procedure-related Adverse Events up to 24 Months
Procedure related adverse events are any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the procedure.
Summary will be based on both Investigators and Medtronic relatedness assessment.
Measured: Implanted surgery to 24 months
Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Some adverse events or treatment failures may lead to additional surgical interventions. Relatedness of these subsequent spinal surgical interventions will be assessed Total events and total number of subjects who have additional surgeries will be summarized. The numbers of revisions (total, preventive and non-preventive), removals, reoperations and other surgeries will also be summarized.
A relatedness determination will be made by the investigator to the original study device and the original study surgery to a subsequent surgical intervention.
Measured: Implanted surgery to 24 months
Assessment of Device Deficiency up to 24 Months
A device deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labeling.
Measured: Implanted surgery to 24 months
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
Main Thoracic Cobb Angle will be calculated from the PA (posteroanterior) TL (thoracic/lumbar) spine radiograph. Main Thoracic Cobb Angle is reported in units of degrees. A positive angle indicates a curve where the apex is to the subject's right of the adjacent vertebra, i.e. the angle opens to the subject's left. A negative angle indicates a curve where the apex is to the subject's left of the adjacent vertebra, i.e., the angle opens to the subject's right.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
The Instrumented Cobb Angle will be calculated from the PA TL Spine radiograph. It will be measured by drawing lines through the superior endplate of the upper instrumented vertebra and the inferior endplate of lower instrumented vertebra. The Instrumented Cobb Angle upper and lower end vertebrae will be defined at PostOp and maintained for all follow-up measurements. Instrumented Cobb Angle will be reported in units of degrees.
Measured: Immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
Thoracic Kyphosis will be calculated from the Lateral TL Spine radiograph and will be measured as the angle between the superior endplate of T5 and the inferior endplate of T12. Thoracic Kyphosis is reported in units of degrees. Positive angle corresponds to kyphotic curvature, whereas negative angle corresponds to lordotic curvature.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
Lumbar Lordosis will be calculated from the Lateral TL Spine radiograph and will be measured as the angle between the superior endplate of S1 and the superior endplate of T12. Lumbar Lordosis is reported in units of degrees. Negative angle corresponds to lordotic curvature, and positive angle corresponds to kyphotic curvature.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
Coronal Balance will be measured from the PA TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (C7PL), and a vertical line is drawn up from the center of the superior endplate of S1 (also known as the center sacral vertical line; "CSVL"). The distance between these lines is recorded in units of millimeters. The sign is positive if C7PL falls to right of the CSVL and negative if it falls to the left as viewed on the PA image.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
Sagittal Balance will be measured from the Lateral TL Spine radiograph. A vertical line is drawn down from the center of the C7 vertebral body (also known as the Sagittal C7 plumb line, "Sagittal C7PL"), and a vertical line drawn from the posterior-superior corner of S1. The distance between these lines is recorded in units of millimeters. The sign is positive if the plumb line falls anterior to the posterior-superior corner of S1 and negative if it falls posterior.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
Total Vertical Thoracic Spine Height will be calculated from the PA TL Spine radiograph. Total Vertical Thoracic Spine Height is defined as the vertical distance between the level of the midpoint of the superior endplate of T1 and the midpoint of the inferior endplate of T12 and will be reported in units of centimeters.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
Total Vertical Spine Height will be calculated from the PA TL Spine radiograph. Total Vertical Spine Length is defined as the vertical distance between the level of the midpoint of the superior endplate of the T1 superior endplate and the midpoint of the superior endplate of S1 and will be reported in units of centimeters.
Measured: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
SRS-22 has 5 domains: function/activity (5 questions), pain (5 questions), self-image (5 questions), mental health (5 questions), and satisfaction with treatment (2 questions). Each question is scored from 1 (worst) to 5 (best). Domain scores are calculated by dividing the sum of answered questions by the number of items answered. The total score is the sum of all answered questions divided by the total number of items answered. Domain and total scores range from 1 (worst) to 5 (best), following the official SRS-22 scoring guidelines: https://www.srs.org/Files/Research/srs-22_sample.pdf
Measured: Baseline to 3, 6, 12, 18, 24, 36, 48 months
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Return to full activity was assessed using the two Function/Activity items of the SRS-22 questionnaire related to activity level: "What is your current level of activity?" and "What is your current level of work/school activity?". For each question, all possible response options-corresponding to scores from 1 (worst) to 5 (best)-were reported together with the distribution of patient answers. Results are presented as the percentage of patients selecting each response option (e.g., 30% selected score 3).
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start12 Aug 2021
- Primary completion11 Apr 2025
- Study completion14 Jan 2026
Why it stopped: The decision to early terminate the study was taken based on the achievement of all primary endpoints at 24-month for every active subjects. In addition, there are currently no plans to use the collected data to seek regulatory approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929678
- Sponsor's protocol ID
- MDT19009SD1901
- Other IDs
- 287046
- Acronym
- BRAIVE IDE
- Status last verified
- Oct 2026
- First submitted
- 24 May 2021
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study of the Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed With Juvenile or Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04929678
- Acronym / sponsor ID
- BRAIVE IDE / MDT19009SD1901
- Keywords
- Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Progressive Scoliosis, BRAIVE, Anterior Vertebral Body Tethering, AVBT, Growth modulation system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to early terminate the study was taken based on the achievement of all primary endpoints at 24-month for every active subjects. In addition, there are currently no plans to use the collected data to seek regulatory approval.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Braive™ Growth Modulation System (Braive™ GMS) | Experimental | Device: Braive™ Growth Modulation System (Braive™ GMS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Has a diagnosis of juvenile or adolescent idiopathic scoliosis
- Is skeletally immature with a Sanders Score of ≥2 to ≤5
- Has failed conservative care as per investigator's assessment
- Has a main thoracic Cobb angle between 30 and 60 degrees
- Has a Lenke Classification of 1A, 1B, or 1C
Key exclusion criteria (19 listed)
- A subject will be excluded from participating in this study for any of the following reasons:
- Has undergone previous spinal fusion procedure(s) at the affected levels
- Is pregnant or plans to become pregnant within the first 24-months of the study
- Has a curve that requires instrumentation below L1
- Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
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 |
|---|---|---|
| Braive™ Growth Modulation System (Braive™ GMS)The Braive™ GMS is designed as a growth-modulation, non-fusion technique, which utilizes patients' remaining growth potential to limit further progression of the curve, to provide correction of the thoracic spine, and allow continued growth while maintaining mobility. The system consists of the following components: Braid, Fixed Angle Screws (FAS), Plate, and Break-Off Set Screw. | Device | Braive™ Growth Modulation System (Braive™ GMS) |
Primary outcome
Summary of Device-related Adverse Events up to 24 Months
Time frame: Implanted surgery to 24 months
Device related adverse events are any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the investigational medical device whether anticipated or unanticipated. Summary will be based on both Investigators and Medtronic relatedness assessment.
15 secondary outcomes
Assessment of Procedure-related Adverse Events up to 24 Months
Time frame: Implanted surgery to 24 months
Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Time frame: Implanted surgery to 24 months
Assessment of Device Deficiency up to 24 Months
Time frame: Implanted surgery to 24 months
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
Time frame: Immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 Months
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
Time frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24, 36, 48 months
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Time frame: Baseline to 3, 6, 12, 18, 24, 36, 48 months
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Time frame: 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braive™ Growth Modulation System (Braive™ GMS) in people with Juvenile Idiopathic Scoliosis and Adolescent Idiopathic Scoliosis, run by Medtronic Spinal and Biologics at 4 sites in 3 countries.
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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Summary of Device-related Adverse Events up to 24 Months (time frame: Implanted surgery to 24 months). 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 28 Oct 2026.