Trial Outcomes & Findings for Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (NCT NCT04929678)
NCT ID: NCT04929678
Last Updated: 2026-03-20
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Implanted surgery to 24 months
Results posted on
2026-03-20
Participant Flow
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.
Participant milestones
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
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|---|---|
|
24-Month Follow-Up
STARTED
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10
|
|
24-Month Follow-Up
COMPLETED
|
9
|
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24-Month Follow-Up
NOT COMPLETED
|
1
|
|
Follow-up Until Skeletal Maturity
STARTED
|
9
|
|
Follow-up Until Skeletal Maturity
COMPLETED
|
1
|
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Follow-up Until Skeletal Maturity
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
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|---|---|
|
24-Month Follow-Up
Withdrawal by Subject
|
1
|
|
Follow-up Until Skeletal Maturity
Study Early Termination (Exited per Sponsor's Request)
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8
|
Baseline Characteristics
Radiographic assessments performed by the study site according to their standard of care.
Baseline characteristics by cohort
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Age, Continuous
|
11.9 Years
STANDARD_DEVIATION 1.8 • n=10 Participants
|
|
Sex: Female, Male
Female
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9 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=10 Participants
|
|
Radiographic Cobb Angles
Main Thoracic Cobb Angle (Pre-Op)
|
48.5 Degrees
STANDARD_DEVIATION 6.8 • n=10 Participants • Radiographic assessments performed by the study site according to their standard of care.
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|
Radiographic Cobb Angles
Proximal Thoracic Cobb Angle (Pre-Op)
|
-27.8 Degrees
STANDARD_DEVIATION 5.5 • n=8 Participants • Radiographic assessments performed by the study site according to their standard of care.
|
|
Radiographic Cobb Angles
Thoracolumbar/Lumbar Cobb Angle (Pre-Op)
|
-29.1 Degrees
STANDARD_DEVIATION 6.9 • n=8 Participants • Radiographic assessments performed by the study site according to their standard of care.
|
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Thoracic Kyphosis (Pre-Op)
Positive at Baseline (Kyphotic)
|
18 Degrees
STANDARD_DEVIATION 7.5 • n=6 Participants • Radiographic assessments performed by the study site according to their standard of care.
|
|
Thoracic Kyphosis (Pre-Op)
Negative at Baseline (Lordotic)
|
-6 Degrees
STANDARD_DEVIATION 1.4 • n=2 Participants • Radiographic assessments performed by the study site according to their standard of care.
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|
Thoracic Kyphosis (Pre-Op)
Absolute Values
|
15 Degrees
STANDARD_DEVIATION 8.5 • n=8 Participants • Radiographic assessments performed by the study site according to their standard of care.
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Lumbar Lordosis (Pre-Op)
|
-51.9 Degrees
STANDARD_DEVIATION 16.8 • n=7 Participants • Radiographic assessments performed by the study site according to their standard of care.
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Coronal Balance (Pre-Op)
Positive at Baseline
|
26.2 millimeters
STANDARD_DEVIATION 9.3 • n=5 Participants • Radiographic assessments performed by the study site according to their standard of care.
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|
Coronal Balance (Pre-Op)
Negative at Baseline
|
-6.9 millimeters
STANDARD_DEVIATION 7.9 • n=3 Participants • Radiographic assessments performed by the study site according to their standard of care.
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|
Coronal Balance (Pre-Op)
Absolute Values
|
19 millimeters
STANDARD_DEVIATION 12.9 • n=8 Participants • Radiographic assessments performed by the study site according to their standard of care.
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|
Sagittal Balance (Pre-Op)
Positive at Baseline
|
34 millimeters
STANDARD_DEVIATION 24.3 • n=3 Participants • Radiographic assessments performed by the study site according to their standard of care.
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|
Sagittal Balance (Pre-Op)
Negative at Baseline
|
-8 millimeters
STANDARD_DEVIATION 8.1 • n=4 Participants • Radiographic assessments performed by the study site according to their standard of care.
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Sagittal Balance (Pre-Op)
Absolute Values
|
19.1 millimeters
STANDARD_DEVIATION 20.6 • n=7 Participants • Radiographic assessments performed by the study site according to their standard of care.
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Total Vertical Thoracic Spine Height (T1-T12) And Total Vertical Spine Height (T1-S1)
Total Vertical Thoracic Spine Height (Pre-Op)
|
24.9 Centimeters
STANDARD_DEVIATION 2.8 • n=7 Participants • Radiographic assessments performed by the study site according to their standard of care.
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Total Vertical Thoracic Spine Height (T1-T12) And Total Vertical Spine Height (T1-S1)
Total Vertical Spine Height (Pre-Op)
|
39.7 Centimeters
STANDARD_DEVIATION 3.9 • n=7 Participants • Radiographic assessments performed by the study site according to their standard of care.
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SRS-22 Patient Questionnaire (Pre-Op)
Function
|
4.8 Scores on a scale 1 (worst) to 5 (best)
STANDARD_DEVIATION 0.3 • n=10 Participants
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SRS-22 Patient Questionnaire (Pre-Op)
Pain
|
4.3 Scores on a scale 1 (worst) to 5 (best)
STANDARD_DEVIATION 0.4 • n=10 Participants
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SRS-22 Patient Questionnaire (Pre-Op)
Self-Image
|
4.0 Scores on a scale 1 (worst) to 5 (best)
STANDARD_DEVIATION 0.4 • n=10 Participants
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|
SRS-22 Patient Questionnaire (Pre-Op)
Mental Health
|
4.2 Scores on a scale 1 (worst) to 5 (best)
STANDARD_DEVIATION 0.6 • n=10 Participants
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SRS-22 Patient Questionnaire (Pre-Op)
Satisfaction
|
4.2 Scores on a scale 1 (worst) to 5 (best)
STANDARD_DEVIATION 0.8 • n=10 Participants
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SRS-22 Patient Questionnaire (Pre-Op)
Total Score
|
4.3 Scores on a scale 1 (worst) to 5 (best)
STANDARD_DEVIATION 0.3 • n=10 Participants
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PRIMARY outcome
Timeframe: Implanted surgery to 24 monthsDevice 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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Summary of Device-related Adverse Events up to 24 Months
AEs Related to Study Device by Investigator Assessment
|
5 Number of Adverse Events (AEs) Reported
|
|
Summary of Device-related Adverse Events up to 24 Months
AEs Related to Study Device by Medtronic Assessment
|
5 Number of Adverse Events (AEs) Reported
|
|
Summary of Device-related Adverse Events up to 24 Months
Serious AEs Related to Study Device by Investigator Assessment
|
3 Number of Adverse Events (AEs) Reported
|
|
Summary of Device-related Adverse Events up to 24 Months
Serious AEs Related to Study Device by Medtronic Assessment
|
3 Number of Adverse Events (AEs) Reported
|
SECONDARY outcome
Timeframe: Implanted surgery to 24 monthsProcedure 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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Assessment of Procedure-related Adverse Events up to 24 Months
AEs Related to Study Procedure by Medtronic Assessment
|
29 Number of Adverse Events (AEs) Reported
|
|
Assessment of Procedure-related Adverse Events up to 24 Months
AEs Related to Study Procedure by Investigator Assessment
|
28 Number of Adverse Events (AEs) Reported
|
|
Assessment of Procedure-related Adverse Events up to 24 Months
Serious AEs Related to Study Procedure by Investigator Assessment
|
1 Number of Adverse Events (AEs) Reported
|
|
Assessment of Procedure-related Adverse Events up to 24 Months
Serious AEs Related to Study Procedure by Medtronic Assessment
|
2 Number of Adverse Events (AEs) Reported
|
SECONDARY outcome
Timeframe: Implanted surgery to 24 monthsPopulation: 4 out of 10 patients treated underwent additional surgeries. 1 patient withdrew from the study and underwent revision surgery after exiting the study; therefore, the related data is not included in this analysis.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
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|---|---|
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Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Total Subsequent Spinal Surgical Intervention
|
3 Number of Secondary Spinal Surgeries
|
|
Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Removal Surgeries
|
0 Number of Secondary Spinal Surgeries
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|
Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Reoperation Surgeries
|
2 Number of Secondary Spinal Surgeries
|
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Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Revision, Non-preventive surgeries
|
1 Number of Secondary Spinal Surgeries
|
|
Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.
Revision, Preventive Surgeries
|
0 Number of Secondary Spinal Surgeries
|
SECONDARY outcome
Timeframe: Implanted surgery to 24 monthsA 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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Assessment of Device Deficiency up to 24 Months
Total DDs
|
7 Number of Device Deficiencies (DDs)
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|
Assessment of Device Deficiency up to 24 Months
DDs related to wrong technique in device usage process
|
1 Number of Device Deficiencies (DDs)
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|
Assessment of Device Deficiency up to 24 Months
DDs related to Product Issues
|
6 Number of Device Deficiencies (DDs)
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
PostOp Change from PreOp (Baseline)
|
-20 Degrees
Standard Deviation 11.4
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Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
3M Change from PreOp (Baseline)
|
-15.7 Degrees
Standard Deviation 8.3
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|
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
6M Change from PreOp (Baseline)
|
-18.4 Degrees
Standard Deviation 11.1
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|
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
12M Change from PreOp (Baseline)
|
-20 Degrees
Standard Deviation 13.8
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|
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
18M Change from PreOp (Baseline)
|
-20.6 Degrees
Standard Deviation 23.2
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|
Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points
24M Change from PreOp (Baseline)
|
-17.4 Degrees
Standard Deviation 26.2
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SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=8 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
6M Change from PreOp (Baseline)
|
7.4 Degrees
Standard Deviation 4.2
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|
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
12M Change from PreOp (Baseline)
|
9.5 Degrees
Standard Deviation 6.5
|
|
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
PostOp Change from PreOp (Baseline)
|
6.8 Degrees
Standard Deviation 5.7
|
|
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
3M Change from PreOp (Baseline)
|
7.3 Degrees
Standard Deviation 5.9
|
|
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
18M Change from PreOp (Baseline)
|
8.9 Degrees
Standard Deviation 8.7
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|
Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints
24M Change from PreOp (Baseline)
|
6.6 Degrees
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=8 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
PostOp Change from PreOp (Baseline)
|
7.5 Degrees
Standard Deviation 8.4
|
|
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
3M Change from PreOp (Baseline)
|
4.8 Degrees
Standard Deviation 5.9
|
|
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
6M Change from PreOp (Baseline)
|
6.0 Degrees
Standard Deviation 5.7
|
|
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
12M Change from PreOp (Baseline)
|
4.1 Degrees
Standard Deviation 8.3
|
|
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
18M Change from PreOp (Baseline)
|
3.4 Degrees
Standard Deviation 9.2
|
|
Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints
24M Change from PreOp (Baseline)
|
2.4 Degrees
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=8 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
3M Change from PostOp
|
6.8 Degrees
Standard Deviation 4.5
|
|
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
6M Change from PostOp
|
6.0 Degrees
Standard Deviation 7.7
|
|
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
12M Change from PostOp
|
5.1 Degrees
Standard Deviation 10.9
|
|
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
18M Change from PostOp
|
7.9 Degrees
Standard Deviation 18.8
|
|
Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.
24M Change from PostOp
|
12 Degrees
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Change from baseline for Thoracic Kyphosis was analyzed considering 3 groups: subjects with positive values at baseline (kyphotic), subjects with negative values at baseline (lordotic), and all subjects with absolute values. Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=8 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
PostOp Change from PreOp (Positive at Baseline - Kyphotic)
|
2.8 Degrees
Standard Deviation 7.2
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
3M Change from PreOp (Positive at Baseline - Kyphotic)
|
0.5 Degrees
Standard Deviation 7.3
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
6M Change from PreOp (Positive at Baseline - Kyphotic)
|
-0.3 Degrees
Standard Deviation 5.0
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
12M Change from PreOp (Positive at Baseline - Kyphotic)
|
1.7 Degrees
Standard Deviation 6.5
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
18M Change from PreOp (Positive at Baseline - Kyphotic)
|
-0.8 Degrees
Standard Deviation 9.3
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
24M Change from PreOp (Positive at Baseline - Kyphotic)
|
3.4 Degrees
Standard Deviation 13.1
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
PostOp Change from PreOp (Negative at Baseline - Lordotic)
|
6.0 Degrees
Standard Deviation 9.9
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
3M Change from PreOp (Negative at Baseline - Lordotic)
|
4.0 Degrees
Standard Deviation 11.3
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
6M Change from PreOp (Negative at Baseline - Lordotic)
|
4.5 Degrees
Standard Deviation 13.4
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
12M Change from PreOp (Negative at Baseline - Lordotic)
|
5.0 Degrees
Standard Deviation 8.5
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
18M Change from PreOp (Negative at Baseline - Lordotic)
|
4.5 Degrees
Standard Deviation 10.6
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
24M Change from PreOp (Negative at Baseline - Lordotic)
|
6.5 Degrees
Standard Deviation 13.4
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
PostOp Change from PreOp (Baseline - All Absolute Values)
|
6.6 Degrees
Standard Deviation 4.2
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
3M Change from PreOp (Baseline - All Absolute Values)
|
6.1 Degrees
Standard Deviation 4.3
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
6M Change from PreOp (Baseline - All Absolute Values)
|
5.1 Degrees
Standard Deviation 4.4
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
12M Change from PreOp (Baseline - All Absolute Values)
|
5.5 Degrees
Standard Deviation 4.0
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
18M Change from PreOp (Baseline - All Absolute Values)
|
7.6 Degrees
Standard Deviation 4.2
|
|
Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints
24M Change from PreOp (Baseline - All Absolute Values)
|
10.3 Degrees
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=7 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
PostOp Change from PreOp (Baseline)
|
6.6 Degrees
Standard Deviation 9.8
|
|
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
3M Change from PreOp (Baseline)
|
-1.7 Degrees
Standard Deviation 7.1
|
|
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
6M Change from PreOp (Baseline)
|
-2.6 Degrees
Standard Deviation 6.7
|
|
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
12M Change from PreOp (Baseline)
|
-5.9 Degrees
Standard Deviation 6.4
|
|
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
18M Change from PreOp (Baseline)
|
-0.3 Degrees
Standard Deviation 8.6
|
|
Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.
24M Change from PreOp (Baseline)
|
7.1 Degrees
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Change from baseline for Coronal Balance was analyzed considering 3 groups: subjects with positive values at baseline, subjects with negative values at baseline, and all subjects with absolute values. Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=8 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
PostOp Change from PreOp (Positive at Baseline)
|
-32.7 Millimeters
Standard Deviation 19.8
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
3M Change from PreOp (Positive at Baseline)
|
-14.6 Millimeters
Standard Deviation 18.4
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
6M Change from PreOp (Positive at Baseline)
|
-20.2 Millimeters
Standard Deviation 18.1
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
12M Change from PreOp (Positive at Baseline)
|
-26.2 Millimeters
Standard Deviation 13.4
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
18M Change from PreOp (Positive at Baseline)
|
-23 Millimeters
Standard Deviation 15.4
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
24M Change from PreOp (Positive at Baseline)
|
-26.5 Millimeters
Standard Deviation 15.9
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
PostOp Change from PreOp (Negative at Baseline)
|
1.5 Millimeters
Standard Deviation 2.2
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
3M Change from PreOp (Negative at Baseline)
|
-2.9 Millimeters
Standard Deviation 6.2
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
6M Change from PreOp (Negative at Baseline)
|
-3.1 Millimeters
Standard Deviation 8.7
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
12M Change from PreOp (Negative at Baseline)
|
-2.3 Millimeters
Standard Deviation 5.2
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
18M Change from PreOp (Negative at Baseline)
|
-5 Millimeters
Standard Deviation 11.4
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
24M Change from PreOp (Negative at Baseline)
|
-3.1 Millimeters
Standard Deviation 5.4
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
PostOp Change from PreOp (All Absolute Values)
|
21 Millimeters
Standard Deviation 22
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
3M Change from PreOp (All Absolute Values)
|
11.8 Millimeters
Standard Deviation 14.2
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
6M Change from PreOp (All Absolute Values)
|
15.5 Millimeters
Standard Deviation 15.1
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
12M Change from PreOp (All Absolute Values)
|
17.8 Millimeters
Standard Deviation 15.5
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
18M Change from PreOp (All Absolute Values)
|
16.2 Millimeters
Standard Deviation 14.9
|
|
Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.
24M Change from PreOp (All Absolute Values)
|
17.3 Millimeters
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Change from baseline for Sagittal Balance was analyzed considering 3 groups: subjects with positive values at baseline, subjects with negative values at baseline, and all subjects with absolute values. Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=7 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
PostOp Change from PreOp (Positive at Baseline)
|
-10.7 Millimeters
Standard Deviation 29
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
3M Change from PreOp (Positive at Baseline)
|
-22.3 Millimeters
Standard Deviation 34.1
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
6M Change from PreOp (Positive at Baseline)
|
-30.3 Millimeters
Standard Deviation 23
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
12M Change from PreOp (Positive at Baseline)
|
-22.7 Millimeters
Standard Deviation 19.9
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
18M Change from PreOp (Positive at Baseline)
|
-24.6 Millimeters
Standard Deviation 4.5
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
24M Change from PreOp (Positive at Baseline)
|
-35.7 Millimeters
Standard Deviation 21.4
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
PostOp Change from PreOp (Negative at Baseline)
|
15.3 Millimeters
Standard Deviation 25.5
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
3M Change from PreOp (Negative at Baseline)
|
7.4 Millimeters
Standard Deviation 10.8
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
6M Change from PreOp (Negative at Baseline)
|
1.9 Millimeters
Standard Deviation 10.6
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
12M Change from PreOp (Negative at Baseline)
|
10.1 Millimeters
Standard Deviation 17
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
18M Change from PreOp (Negative at Baseline)
|
-1.3 Millimeters
Standard Deviation 5.1
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
24M Change from PreOp (Negative at Baseline)
|
-3 Millimeters
Standard Deviation 8.6
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
PostOp Change from PreOp (All Absolute Values)
|
21.3 Millimeters
Standard Deviation 17
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
3M Change from PreOp (All Absolute Values)
|
16.6 Millimeters
Standard Deviation 20.2
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
6M Change from PreOp (All Absolute Values)
|
16.7 Millimeters
Standard Deviation 19.2
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
12M Change from PreOp (All Absolute Values)
|
17.1 Millimeters
Standard Deviation 16.1
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
18M Change from PreOp (All Absolute Values)
|
12.9 Millimeters
Standard Deviation 11.3
|
|
Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints
24M Change from PreOp (All Absolute Values)
|
19.3 Millimeters
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=7 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
PostOp Change from PreOp (Baseline)
|
1.0 Centimeters
Standard Deviation 1.9
|
|
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
3M Change from PreOp (Baseline)
|
0 Centimeters
Standard Deviation 1.6
|
|
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
6M Change from PreOp (Baseline)
|
0.1 Centimeters
Standard Deviation 1.7
|
|
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
12M Change from PreOp (Baseline)
|
1.2 Centimeters
Standard Deviation 1.8
|
|
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
18M Change from PreOp (Baseline)
|
1.3 Centimeters
Standard Deviation 2.0
|
|
Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.
24M Change from PreOp (Baseline)
|
1.4 Centimeters
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 monthsPopulation: Radiographic assessments performed by the study site according to their standard of care. 1 patient withdrew from the study before 18 Month Follow-up.
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.
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=7 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
PostOp Change from PreOp (Baseline)
|
1.3 Centimeters
Standard Deviation 2.0
|
|
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
3M Change from PreOp (Baseline)
|
0.3 Centimeters
Standard Deviation 2.2
|
|
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
6M Change from PreOp (Baseline)
|
1.1 Centimeters
Standard Deviation 2.5
|
|
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
12M Change from PreOp (Baseline)
|
2.0 Centimeters
Standard Deviation 3.5
|
|
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
18M Change from PreOp (Baseline)
|
2.2 Centimeters
Standard Deviation 3.4
|
|
Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints
24M Change from PreOp (Baseline)
|
2.5 Centimeters
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline to 3, 6, 12, 18, 24 monthsPopulation: 1 patient did not complete the questionnaire at 3-Month Follow-up (protocol deviation) and withdrew from the study before 18 Month Follow-up
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
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Function - 3M Change from PreOp (Baseline)
|
-0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.3
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Function - 6M Change from PreOp (Baseline)
|
0 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.2
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Function - 12M Change from PreOp (Baseline)
|
0 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.3
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Function - 18M Change from PreOp (Baseline)
|
0 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Function - 24M Change from PreOp (Baseline)
|
0.1 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.2
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Pain - 3M Change from PreOp (Baseline)
|
-0.1 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.5
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Pain - 6M Change from PreOp (Baseline)
|
0.2 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.3
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Pain - 12M Change from PreOp (Baseline)
|
0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.5
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Pain - 18M Change from PreOp (Baseline)
|
0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Pain - 24M Change from PreOp (Baseline)
|
0.4 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.3
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Self-Image - 3M Change from PreOp (Baseline)
|
0.5 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Self-Image - 6M Change from PreOp (Baseline)
|
0.6 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Self-Image - 12M Change from PreOp (Baseline)
|
0.4 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.5
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Self-Image - 18M Change from PreOp (Baseline)
|
0.4 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.5
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Self-Image - 24M Change from PreOp (Baseline)
|
0.4 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.6
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Mental Health - 3M Change from PreOp (Baseline)
|
0.2 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Mental Health - 6M Change from PreOp (Baseline)
|
0.4 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.7
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Mental Health - 12M Change from PreOp (Baseline)
|
0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.7
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Mental Health - 18M Change from PreOp (Baseline)
|
0.7 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.6
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Mental Health - 24M Change from PreOp (Baseline)
|
0.5 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.7
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Satisfaction - 3M Change from PreOp (Baseline)
|
0.6 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.8
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Satisfaction - 6M Change from PreOp (Baseline)
|
0.4 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.9
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Satisfaction - 12M Change from PreOp (Baseline)
|
0 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 1.2
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Satisfaction - 18M Change from PreOp (Baseline)
|
0.1 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 1.2
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Satisfaction - 24M Change from PreOp (Baseline)
|
0.1 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 1.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Total Score - 3M Change from PreOp (Baseline)
|
0.1 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.3
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Total Score - 6M Change from PreOp (Baseline)
|
0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.3
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Total Score - 12M Change from PreOp (Baseline)
|
0.2 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Total Score - 18M Change from PreOp (Baseline)
|
0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
|
Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint
Total Score - 24M Change from PreOp (Baseline)
|
0.3 Scores on a scale 1 (worst) to 5 (best)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 months.Population: 1 patient did not complete the questionnaire at 3-Month Follow-up (protocol deviation)
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).
Outcome measures
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=9 Participants
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of activity: Full activities without restriction (5)
|
3 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of activity: Bedridden (1)
|
0 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of activity: Primarily no activity (2)
|
0 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of activity: Light labor and light sports (3)
|
3 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of activity: Moderate labor and moderate sports (4)
|
3 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of work/school activity: 0% Normal (1)
|
0 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of work/school activity: 25% Normal (2)
|
0 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of work/school activity: 50% Normal (3)
|
1 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of work/school activity: 75% (4) Normal
|
4 Participants
|
|
Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Current level of work/school activity: 100% Normal (5)
|
4 Participants
|
Adverse Events
Braive™ Growth Modulation System (Braive™ GMS)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 participants at risk
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Product Issues
Device breakage
|
20.0%
2/10 • Number of events 2 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
Other adverse events
| Measure |
Braive™ Growth Modulation System (Braive™ GMS)
n=10 participants at risk
BRAIVE IDE is a single arm study. Subjects were enrolled and implanted with the Braive™ Growth Modulation System (Braive™ GMS).
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Coronavirus infection
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Ear Infection
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Otitis externa
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
2/10 • Number of events 2 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 3 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
20.0%
2/10 • Number of events 2 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
40.0%
4/10 • Number of events 4 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
5/10 • Number of events 5 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
50.0%
5/10 • Number of events 5 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
|
Social circumstances
Patient dissatisfaction with treatment
|
10.0%
1/10 • Number of events 1 • From enrollment until 24-month follow-up
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. Medtronic Assessment was used for Seriousness assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The most restrictive disclosure requires that any publication be submitted to the sponsor for review at least sixty (60) days prior to submission, and the investigator must remove any identified confidential information and correct technical errors as requested by the sponsor. Furthermore, upon the sponsor's request, publication may be delayed for up to an additional ninety (90) days to allow protection of patentable or copyrightable material.
- Publication restrictions are in place
Restriction type: OTHER