An interventional study of Braive™ Growth Modulation System (Braive™ GMS) in Juvenile Idiopathic Scoliosis and Adolescent Idiopathic Scoliosis, sponsored by Medtronic Spinal and Biologics. Terminated at 4 sites in 3 countries. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Medtronic Spinal and Biologics (part of Medtronic) · Not applicable, Interventional, and Treatment
Among 41 studies in Scoliosis with a site in Canada — 11 open to participants now, 13 under way, none of them phase 3. Scoliosis · Canada.
Among the 41 studies in Scoliosis with a site in Canada, this one is the 26th largest by enrollment of the 30 interventional ones, is one of 4 that started in 2021, is one of 19 with no phase, and was the 35th registered.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's enrollment of 10 is below the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →11 of the 41 studies in Scoliosis with a site in Canada are open now, in 6 countries. Each count lists the studies.
Of the 117 Scoliosis studies recruiting now, 23 (20%) set no upper age limit and 88 (75%) stop at 75 or younger; 98 take children under 18; 14 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →41 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 4 started in 2021.
Median enrollment 40 across the 30 interventional studies, 273 across the 11 observational. Of the 24 that completed or were terminated, 3 (13%) have results posted.
2 of 41 have an industry lead sponsor. The 10 most frequent:
Medtronic Spinal and Biologics is the lead sponsor of 57 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Medtronic Spinal and Biologics has 2 studies filed under Scoliosis — fewer than ten, so there is no comparison to draw.
3 of the studies in Scoliosis with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06357234IWK Health CentreAprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery | 2027-03 |
| NCT07737886St. Justine's HospitalFeasibility, Acceptability, and Preliminary Effects of Virtual Reality for Pain, Anxiety and Recovery Enhancement of Children Post-scoliosis Surgical Repair | 2027-05-31 |
| NCT05538871University of AlbertaBody Structure and Capacity Evaluation of Adults With Scoliosis | 2027-06 |
Among the 41 studies in Scoliosis with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A subject must meet all of the following inclusion criteria to participate in this study:
Exclusion Criteria:
A subject will be excluded from participating in this study for any of the following reasons:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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.
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.
Time frame: Implanted surgery to 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees.
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
Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees.
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.
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.
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
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.
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.
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.
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.
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.
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
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.
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.
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.
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
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.
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
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
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)
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).
Time frame: 3 months.
Enrollment started on 24-Jun-2021, with the activation of the first site. The first subject was enrolled on 12-Aug-2021. A total of 10 subjects were enrolled and underwent the Braive™ GMS procedure, with the last surgery of the study occurring on 13-Feb-2023. Enrollment was discontinued on 10-Mar-2023.
| Milestone | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Started | 9 |
| Completed | 1 |
| Not completed | 8 |
| Withdrew: Study early termination (exited per sponsor's request) | 8 |
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.
| Number of Adverse Events (AEs) Reported | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| AEs Related to Study Device by Investigator Assessment | 5 |
| AEs Related to Study Device by Medtronic Assessment | 5 |
| Serious AEs Related to Study Device by Investigator Assessment | 3 |
| Serious AEs Related to Study Device by Medtronic Assessment | 3 |
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.
| Number of Adverse Events (AEs) Reported | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| AEs Related to Study Procedure by Investigator Assessment | 28 |
| AEs Related to Study Procedure by Medtronic Assessment | 29 |
| Serious AEs Related to Study Procedure by Investigator Assessment | 1 |
| Serious AEs Related to Study Procedure by Medtronic Assessment | 1 |
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.
| Number of Secondary Spinal Surgeries | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Total Subsequent Spinal Surgical Intervention | 3 |
| Removal Surgeries | 0 |
| Reoperation Surgeries | 2 |
| Revision, Non-preventive surgeries | 1 |
| Revision, Preventive Surgeries | 0 |
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.
| Number of Device Deficiencies (DDs) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Total DDs | 7 |
| DDs related to wrong technique in device usage process | 1 |
| DDs related to Product Issues | 6 |
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.
| Degrees | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Baseline) | -22.5 ± 11.4 |
| 3M Change from PreOp (Baseline) | -16 ± 9.2 |
| 6M Change from PreOp (Baseline) | -18.4 ± 11.1 |
| 12M Change from PreOp (Baseline) | -20 ± 13.8 |
| 18M Change from PreOp (Baseline) | -20.6 ± 23.2 |
| 24M Change from PreOp (Baseline) | -17.4 ± 26.2 |
| 36M Change from PreOp (Baseline) | -12 ± 28.6 |
| 48M Change from PreOp (Baseline) | -47 |
Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees.
| Degrees | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Baseline) | 7.4 ± 5.2 |
| 3M Change from PreOp (Baseline) | 9.0 ± 6.4 |
| 6M Change from PreOp (Baseline) | 7.8 ± 3.9 |
| 12M Change from PreOp (Baseline) | 11 ± 6.8 |
| 18M Change from PreOp (Baseline) | 11 ± 8.9 |
| 24M Change from PreOp (Baseline) | 8.9 ± 10 |
| 36M Change from PreOp (Baseline) | 11.3 ± 16.5 |
| 48M Change from PreOp (Baseline) | 29 |
Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees.
| Degrees | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Baseline) | 9.0 ± 9.1 |
| 3M Change from PreOp (Baseline) | 6.2 ± 7.1 |
| 6M Change from PreOp (Baseline) | 7.5 ± 6.3 |
| 12M Change from PreOp (Baseline) | 6.7 ± 9.1 |
| 18M Change from PreOp (Baseline) | 6.8 ± 10.4 |
| 24M Change from PreOp (Baseline) | 5.4 ± 10.1 |
| 36M Change from PreOp (Baseline) | 2.6 ± 8.8 |
| 48M Change from PreOp (Baseline) | 23 |
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.
| Degrees | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| 3M Change from PostOp | 7.7 ± 6.3 |
| 6M Change from PostOp | 5.8 ± 7.0 |
| 12M Change from PostOp | 4.3 ± 10.6 |
| 18M Change from PostOp | 4.1 ± 18.4 |
| 24M Change from PostOp | 6.7 ± 20.3 |
| 36M Change from PostOp | 10 ± 22.5 |
| 48M Change from PostOp | -13 |
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.
| Degrees | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Positive at Baseline - Kyphotic) | 1.6 ± 7.3 |
| 3M Change from PreOp (Positive at Baseline - Kyphotic) | 3.3 ± 8.7 |
| 6M Change from PreOp (Positive at Baseline - Kyphotic) | -0.3 ± 4.5 |
| 12M Change from PreOp (Positive at Baseline - Kyphotic) | 2.1 ± 6.1 |
| 18M Change from PreOp (Positive at Baseline - Kyphotic) | -0.1 ± 8.3 |
| 24M Change from PreOp (Positive at Baseline - Kyphotic) | 3.4 ± 13.6 |
| PostOp Change from PreOp (Negative at Baseline - Lordotic) | 6.0 ± 9.9 |
| 3M Change from PreOp (Negative at Baseline - Lordotic) | 4.0 ± 11.3 |
| 6M Change from PreOp (Negative at Baseline - Lordotic) | 4.5 ± 13.4 |
| 12M Change from PreOp (Negative at Baseline - Lordotic) | 5.0 ± 8.5 |
| 18M Change from PreOp (Negative at Baseline - Lordotic) | 4.5 ± 10.6 |
| 24M Change from PreOp (Negative at Baseline - Lordotic) | 6.5 ± 13.4 |
| PostOp Change from PreOp (Baseline - All Absolute Values) | 6.6 ± 3.9 |
| 3M Change from PreOp (Baseline - All Absolute Values) | 7.2 ± 5.4 |
| 6M Change from PreOp (Baseline - All Absolute Values) | 4.6 ± 4.4 |
| 12M Change from PreOp (Baseline - All Absolute Values) | 5.3 ± 3.9 |
| 18M Change from PreOp (Baseline - All Absolute Values) | 7.1 ± 3.8 |
| 24M Change from PreOp (Baseline - All Absolute Values) | 11.2 ± 6.4 |
| 36M Change from PreOp (Positive at Baseline | 3.0 ± 17.1 |
| 48M Change from PreOp (Positive at Baseline) | -5.0 |
| 36M Change from PreOp (Negative at Baseline | -9.0 |
| 36M Change from PreOp (Baseline - All Absolute Values) | 14.1 ± 5.7 |
| 48M Change from PreOp (Baseline - All Absolute Values) | 5 |
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.
| Degrees | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Baseline) | 5.6 ± 9.4 |
| 3M Change from PreOp (Baseline) | -3.3 ± 7.0 |
| 6M Change from PreOp (Baseline) | -1.5 ± 6.9 |
| 12M Change from PreOp (Baseline) | -7.7 ± 7.2 |
| 18M Change from PreOp (Baseline) | -2.3 ± 9.5 |
| 24M Change from PreOp (Baseline) | -3.3 ± 10.8 |
| 36M Change from PreOp (Baseline) | -6.7 ± 11.9 |
| 48M Change from PreOp (Baseline) | -19 |
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.
| Millimeters | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Positive at Baseline) | -32.7 ± 19.8 |
| 3M Change from PreOp (Positive at Baseline) | -12.2 ± 17.5 |
| 6M Change from PreOp (Positive at Baseline) | -16.8 ± 18.2 |
| 12M Change from PreOp (Positive at Baseline) | -21.8 ± 16.1 |
| 18M Change from PreOp (Positive at Baseline) | -18.4 ± 16.8 |
| 24M Change from PreOp (Positive at Baseline) | -17.6 ± 16.7 |
| PostOp Change from PreOp (Negative at Baseline) | 1.5 ± 2.2 |
| 3M Change from PreOp (Negative at Baseline) | -2.9 ± 6.2 |
| 6M Change from PreOp (Negative at Baseline) | -3.1 ± 8.7 |
| 12M Change from PreOp (Negative at Baseline) | -2.3 ± 5.2 |
| 18M Change from PreOp (Negative at Baseline) | -5 ± 11.4 |
| 24M Change from PreOp (Negative at Baseline) | -3.1 ± 5.4 |
| PostOp Change from PreOp (All Absolute Values) | 21 ± 22 |
| 3M Change from PreOp (All Absolute Values) | 10.5 ± 13.9 |
| 6M Change from PreOp (All Absolute Values) | 13.8 ± 15.1 |
| 12M Change from PreOp (All Absolute Values) | 15.8 ± 15.7 |
| 18M Change from PreOp (All Absolute Values) | 14.1 ± 14.9 |
| 24M Change from PreOp (All Absolute Values) | 12.9 ± 14.3 |
| 36M Change from PreOp (Positive at Baseline) | -10 ± 9.7 |
| 48M Change from PreOp (Positive at Baseline) | 0 |
| 36M Change from PreOp (Negative at Baseline) | -11.6 ± 20.6 |
| 36M Change from PreOp (All Absolute Values) | 11.9 ± 10.3 |
| 48M Change from PreOp (All Absolute Values) | 0 |
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.
| Millimeters | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Positive at Baseline) | -10.7 ± 29 |
| 3M Change from PreOp (Positive at Baseline) | -22.3 ± 34.1 |
| 6M Change from PreOp (Positive at Baseline) | -30.3 ± 23 |
| 12M Change from PreOp (Positive at Baseline) | -22.7 ± 19.9 |
| 18M Change from PreOp (Positive at Baseline) | -24.6 ± 4.5 |
| 24M Change from PreOp (Positive at Baseline) | -35.7 ± 21.4 |
| PostOp Change from PreOp (Negative at Baseline) | 15.3 ± 25.5 |
| 3M Change from PreOp (Negative at Baseline) | 5.3 ± 10.4 |
| 6M Change from PreOp (Negative at Baseline) | 1.9 ± 10.6 |
| 12M Change from PreOp (Negative at Baseline) | 8.1 ± 15.4 |
| 18M Change from PreOp (Negative at Baseline) | -1.8 ± 4.6 |
| 24M Change from PreOp (Negative at Baseline) | -2.8 ± 7.5 |
| PostOp Change from PreOp (All Absolute Values) | 21.3 ± 17 |
| 3M Change from PreOp (All Absolute Values) | 14.9 ± 19.3 |
| 6M Change from PreOp (All Absolute Values) | 16.7 ± 19.2 |
| 12M Change from PreOp (All Absolute Values) | 15 ± 16.1 |
| 18M Change from PreOp (All Absolute Values) | 11.8 ± 10.9 |
| 24M Change from PreOp (All Absolute Values) | 17.1 ± 19.4 |
| 36M Change from PreOp (Positive at Baseline) | -21 |
| 36M Change from PreOp (Negative at Baseline) | 3.8 ± 21.5 |
| 48M Change from PreOp (Negative at Baseline) | 28 |
| 36M Change from PreOp (All Absolute Values) | 15.7 ± 13.3 |
| 48M Change from PreOp (All Absolute Values) | 28 |
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.
| Centimeters | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Baseline) | 1.0 ± 1.9 |
| 3M Change from PreOp (Baseline) | 0.2 ± 1.6 |
| 6M Change from PreOp (Baseline) | 0.1 ± 1.7 |
| 12M Change from PreOp (Baseline) | 1.4 ± 1.7 |
| 18M Change from PreOp (Baseline) | 1.5 ± 1.9 |
| 24M Change from PreOp (Baseline) | 1.6 ± 2.3 |
| 36M Change from PreOp (Baseline) | 1.6 ± 2.9 |
| 48M Change from PreOp (Baseline) | 5.6 |
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.
| Centimeters | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PostOp Change from PreOp (Baseline) | 1.3 ± 2.0 |
| 3M Change from PreOp (Baseline) | 0.5 ± 2.1 |
| 6M Change from PreOp (Baseline) | 1.1 ± 2.5 |
| 12M Change from PreOp (Baseline) | 2.0 ± 3.2 |
| 18M Change from PreOp (Baseline) | 2.3 ± 3.1 |
| 24M Change from PreOp (Baseline) | 2.6 ± 3.2 |
| 36M Change from PreOp (Baseline) | 2.4 ± 4.1 |
| 48M Change from PreOp (Baseline) | 7.9 |
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
| Scores on a scale 1 (worst) to 5 (best) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Function - 3M Change from PreOp (Baseline) | -0.3 ± 0.3 |
| Function - 6M Change from PreOp (Baseline) | 0 ± 0.2 |
| Function - 12M Change from PreOp (Baseline) | 0 ± 0.3 |
| Function - 18M Change from PreOp (Baseline) | 0 ± 0.4 |
| Function - 24M Change from PreOp (Baseline) | 0.1 ± 0.2 |
| Pain - 3M Change from PreOp (Baseline) | -0.1 ± 0.5 |
| Pain - 6M Change from PreOp (Baseline) | 0.2 ± 0.3 |
| Pain - 12M Change from PreOp (Baseline) | 0.3 ± 0.5 |
| Pain - 18M Change from PreOp (Baseline) | 0.3 ± 0.4 |
| Pain - 24M Change from PreOp (Baseline) | 0.4 ± 0.3 |
| Self-Image - 3M Change from PreOp (Baseline) | 0.5 ± 0.4 |
| Self-Image - 6M Change from PreOp (Baseline) | 0.6 ± 0.4 |
| Self-Image - 12M Change from PreOp (Baseline) | 0.4 ± 0.5 |
| Self-Image - 18M Change from PreOp (Baseline) | 0.4 ± 0.5 |
| Self-Image - 24M Change from PreOp (Baseline) | 0.4 ± 0.6 |
| Mental Health - 3M Change from PreOp (Baseline) | 0.2 ± 0.4 |
| Mental Health - 6M Change from PreOp (Baseline) | 0.4 ± 0.7 |
| Mental Health - 12M Change from PreOp (Baseline) | 0.3 ± 0.7 |
| Mental Health - 18M Change from PreOp (Baseline) | 0.7 ± 0.6 |
| Mental Health - 24M Change from PreOp (Baseline) | 0.5 ± 0.7 |
| Satisfaction - 3M Change from PreOp (Baseline) | 0.6 ± 0.8 |
| Satisfaction - 6M Change from PreOp (Baseline) | 0.4 ± 0.9 |
| Satisfaction - 12M Change from PreOp (Baseline) | 0 ± 1.2 |
| Satisfaction - 18M Change from PreOp (Baseline) | 0.1 ± 1.2 |
| Satisfaction - 24M Change from PreOp (Baseline) | 0.1 ± 1.4 |
| Total Score - 3M Change from PreOp (Baseline) | 0.1 ± 0.3 |
| Total Score - 6M Change from PreOp (Baseline) | 0.3 ± 0.3 |
| Total Score - 12M Change from PreOp (Baseline) | 0.2 ± 0.4 |
| Total Score - 18M Change from PreOp (Baseline) | 0.3 ± 0.4 |
| Total Score - 24M Change from PreOp (Baseline) | 0.3 ± 0.4 |
| Function - 36M Change from PreOp (Baseline) | 0.1 ± 0.2 |
| Function - 48M Change from PreOp (Baseline) | 0 |
| Pain - 36M Change form PreOp (Baseline) | 0.4 ± 0.3 |
| Pain - 48M Change form PreOp (Baseline) | 0.8 |
| Self-Image - 36M Change form PreOp (Baseline) | 0.4 ± 0.6 |
| Self-Image - 48M Change form PreOp (Baseline) | 1.2 |
| Mental Health - 36M Change form PreOp (Baseline) | 0.6 ± 0.7 |
| Mental Health - 48M Change form PreOp (Baseline) | 2.0 |
| Satisfaction - 36M Change from PreOp (Baseline) | -0.2 ± 1.2 |
| Satisfaction - 48M Change from PreOp (Baseline) | 0 |
| Total Score - 36M Change from PreOp (Baseline) | 0.3 ± 0.3 |
| Total Score - 48M Change from PreOp (Baseline) | 0.9 |
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).
| Participants | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Current level of activity: Bedridden (1) | 0 |
| Current level of activity: Primarily no activity (2) | 0 |
| Current level of activity: Light labor and light sports (3) | 3 |
| Current level of activity: Moderate labor and moderate sports (4) | 3 |
| Current level of activity: Full activities without restriction (5) | 3 |
| Current level of work/school activity: 0% Normal (1) | 0 |
| Current level of work/school activity: 25% Normal (2) | 0 |
| Current level of work/school activity: 50% Normal (3) | 1 |
| Current level of work/school activity: 75% (4) Normal | 4 |
| Current level of work/school activity: 100% Normal (5) | 4 |
Collected over From implantation through study follow-up until skeletal maturity (defined as Risser 5 as assessed by the investigator) or study termination (last subject exited on 14-Jan-2026), whichever occurred first. Follow-up duration varied among subjects due to early study termination up to a maximum of 48 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Braive™ Growth Modulation System (Braive™ GMS) | 0/10 (0%) | 3/10 (30%) | 9/10 (90%) |
| Event | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Device breakageProduct Issues | 2/10 |
| ScoliosisMusculoskeletal and connective tissue disorders | 1/10 |
| Event | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 5/10 |
| Subcutaneous emphysemaSkin and subcutaneous tissue disorders | 5/10 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 4/10 |
| Procedural painInjury, poisoning and procedural complications | 2/10 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/10 |
| Back painMusculoskeletal and connective tissue disorders | 2/10 |
| AtelectasisRespiratory, thoracic and mediastinal disorders | 2/10 |
| ConstipationGastrointestinal disorders | 1/10 |
| NauseaGastrointestinal disorders | 1/10 |
| Coronavirus infectionInfections and infestations | 1/10 |
| Age, Continuous(Years) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Mean | 11.9 ± 1.8 |
| Sex: Female, Male(Participants) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Female | 9 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| United States | 2 |
| United Kingdom | 2 |
| Canada | 6 |
| Radiographic Cobb Angles(Degrees) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Main Thoracic Cobb Angle (Pre-Op) | 48.5 ± 6.8 |
| Proximal Thoracic Cobb Angle (Pre-Op) | -28.4 ± 5.1 |
| Thoracolumbar/Lumbar Cobb Angle (Pre-Op) | -29.4 ± 6.1 |
| Thoracic Kyphosis (Pre-Op)(Degrees) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Positive at Baseline (Kyphotic) | 19.5 ± 9.5 |
| Negative at Baseline (Lordotic) | -6 ± 1.4 |
| Absolute Values | 16.8 ± 10.1 |
| Lumbar Lordosis (Pre-Op)(Degrees) | Braive™ Growth Modulation System (Braive™ GMS) |
|---|---|
| Mean | -49.3 ± 15.4 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2021 to primary completion in Apr 2025, 43 months.
Results were first posted in Mar 2026, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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