The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Mayo Clinic
Rochester, Minnesota, United States
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
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: Baseline 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: Baseline 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: Baseline to 24 months and up to skeletal maturity
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: Baseline to 24 months and up to skeletal maturity
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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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
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 months, and annually until skeletal maturity is reached.
Change from baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at all available postoperative timepoint
The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110. Higher score means better outcome.
Time frame: Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
Status of return to full activity within 3 months per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
SRS-22's subdomain function/activity will be utilized to evaluate the status of return to full activity. The subdomain has 5 items and will be scored on a scale from 1 (worst) to 5 (best). Higher score means better outcome.
Time frame: 3 months.