Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis
Conditions
Keywords
Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Progressive Scoliosis, BRAIVE, Anterior Vertebral Body Tethering, AVBT, Growth modulation system
Brief summary
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
Interventions
DEVICEBraive™ 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.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
A subject must meet all of the following inclusion criteria to participate in this study: * Has a diagnosis of juvenile or adolescent idiopathic scoliosis * Is skeletally immature with a Sanders Score of ≥2 to ≤5 * Has failed conservative care as per investigator's assessment * Has a main thoracic Cobb angle between 30 and 60 degrees * Has a Lenke Classification of 1A, 1B, or 1C * Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative * Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by Parent/legal guardian and/or patient/participant per local requirement.
Exclusion criteria
A subject will be excluded from participating in this study for any of the following reasons: * Has undergone previous spinal fusion procedure(s) at the affected levels * Is pregnant or plans to become pregnant within the first 24-months of the study * Has a curve that requires instrumentation below L1 * Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord) * Has any type of non-idiopathic scoliosis * Has a left-sided curve * Has an associated syndrome * Has a history of malignant hyperthermia * Has an active or significant risk of infection (immunocompromised) * Has inadequate tissue coverage over the operative site as per investigator's assessment * Has a suspected or documented allergy or intolerance to implant materials * Has a major psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference) * Is a ward of the court/state * Has had prior ipsilateral or contralateral chest surgery * Has severe chronic lung disease (e.g., asthma, bronchiectasis) * Has poor bone quality, as determined by the investigator, that may limit anterior fixation * Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions * Concurrent participation in another clinical study that may add additional safety risks and/or confound study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Device-related Adverse Events up to 24 Months | Implanted surgery to 24 months | Device related adverse events are any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the investigational medical device whether anticipated or unanticipated. Summary will be based on both Investigators and Medtronic relatedness assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Procedure-related Adverse Events up to 24 Months | Implanted surgery 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. |
| Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months. | Implanted surgery 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. |
| Assessment of Device Deficiency up to 24 Months | Implanted surgery 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. |
| Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | Proximal Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Proximal Thoracic Cobb Angle is reported in units of degrees. |
| Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | Thoracolumbar/Lumbar Cobb Angle will be calculated from the PA TL spine radiograph. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees. |
| Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points. | Immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints. | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Coronal Balance at All Available Postoperative Timepoints. | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints. | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months | 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. |
| Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint | Baseline to 3, 6, 12, 18, 24 months | 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 |
| Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22) | 3 months. | 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). |
Countries
Canada, United Kingdom, United States
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 11.9 Years STANDARD_DEVIATION 1.8 |
| Coronal Balance (Pre-Op) Absolute Values | 19 millimeters STANDARD_DEVIATION 12.9 |
| Coronal Balance (Pre-Op) Negative at Baseline | -6.9 millimeters STANDARD_DEVIATION 7.9 |
| Coronal Balance (Pre-Op) Positive at Baseline | 26.2 millimeters STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lumbar Lordosis (Pre-Op) | -51.9 Degrees STANDARD_DEVIATION 16.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Radiographic Cobb Angles Main Thoracic Cobb Angle (Pre-Op) | 48.5 Degrees STANDARD_DEVIATION 6.8 |
| Radiographic Cobb Angles Proximal Thoracic Cobb Angle (Pre-Op) | -27.8 Degrees STANDARD_DEVIATION 5.5 |
| Radiographic Cobb Angles Thoracolumbar/Lumbar Cobb Angle (Pre-Op) | -29.1 Degrees STANDARD_DEVIATION 6.9 |
| Region of Enrollment Canada | 6 Participants |
| Region of Enrollment United Kingdom | 2 Participants |
| Region of Enrollment United States | 2 Participants |
| Sagittal Balance (Pre-Op) Absolute Values | 19.1 millimeters STANDARD_DEVIATION 20.6 |
| Sagittal Balance (Pre-Op) Negative at Baseline | -8 millimeters STANDARD_DEVIATION 8.1 |
| Sagittal Balance (Pre-Op) Positive at Baseline | 34 millimeters STANDARD_DEVIATION 24.3 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
| SRS-22 Patient Questionnaire (Pre-Op) Function | 4.8 Scores on a scale 1 (worst) to 5 (best) STANDARD_DEVIATION 0.3 |
| SRS-22 Patient Questionnaire (Pre-Op) Mental Health | 4.2 Scores on a scale 1 (worst) to 5 (best) STANDARD_DEVIATION 0.6 |
| SRS-22 Patient Questionnaire (Pre-Op) Pain | 4.3 Scores on a scale 1 (worst) to 5 (best) STANDARD_DEVIATION 0.4 |
| SRS-22 Patient Questionnaire (Pre-Op) Satisfaction | 4.2 Scores on a scale 1 (worst) to 5 (best) STANDARD_DEVIATION 0.8 |
| SRS-22 Patient Questionnaire (Pre-Op) Self-Image | 4.0 Scores on a scale 1 (worst) to 5 (best) STANDARD_DEVIATION 0.4 |
| SRS-22 Patient Questionnaire (Pre-Op) Total Score | 4.3 Scores on a scale 1 (worst) to 5 (best) STANDARD_DEVIATION 0.3 |
| Thoracic Kyphosis (Pre-Op) Absolute Values | 15 Degrees STANDARD_DEVIATION 8.5 |
| Thoracic Kyphosis (Pre-Op) Negative at Baseline (Lordotic) | -6 Degrees STANDARD_DEVIATION 1.4 |
| Thoracic Kyphosis (Pre-Op) Positive at Baseline (Kyphotic) | 18 Degrees STANDARD_DEVIATION 7.5 |
| 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 |
| 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 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 3 / 10 |
Outcome results
None listed