Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis

Study Overview
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Brief Summary
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The purpose of this study is to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.

Official Title
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A Prospective, Multi-Center Study of the Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed With Juvenile or Adolescent Idiopathic Scoliosis

Conditions
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Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: Braive™ Growth Modulation System (Braive™ GMS)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Braive™ Growth Modulation System (Braive™ GMS)<br> | Device: Braive™ Growth Modulation System (Braive™ GMS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-operative main thoracic Cobb angle compared to the post-operative Cobb angle at 24 months. | Main Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Main Thoracic Cobb Angle is measured by drawing lines through the superior endplate of the upper end vertebra and the inferior endplate of the lower end vertebra that yields the greatest angle of curvature of the structural thoracic curve (at or below T2 and at or above T11-T12). Main Thoracic Cobb Angle will be reported in units of degrees. The change in Cobb Angle will be calculated from two points as the value at the first time point minus the value at the later time point. | Baseline to 24 months. | 
| Number of secondary spinal surgeries defined as treatment failure up to 24 months postoperatively | CEC adjudication of secondary surgeries will be used for this endpoint. | Immediately after surgery to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in main thoracic Cobb angle at all available postoperative timepoints | Main Thoracic Cobb Angle will be calculated from the PA TL spine radiograph. The Main Thoracic Cobb Angle is measured by drawing lines through the superior endplate of the upper end vertebra and the inferior endplate of the lower end vertebra that yields the greatest angle of curvature of the structural thoracic curve (at or below T2 and at or above T11-T12). Main Thoracic Cobb Angle will be reported in units of degrees. The change in Cobb Angle will be calculated from two points as the value at the first time point minus the value at the later time point. | Baseline, immediately after the surgery, 3, 6, 12, 18, 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 measured by drawing two lines - one parallel to the superior endplate of the upper end vertebra and the other parallel to the inferior endplate of the lower end vertebra. The upper and lower end vertebrae will be the vertebrae having the maximum tilts toward the apex of the thoracolumbar/lumbar curve. Thoracolumbar/Lumbar Cobb Angle will be reported in units of degrees. | Baseline, 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 will be reported in units of degrees. Positive angle corresponds to kyphotic curvature, whereas negative angle corresponds to lordotic curvature. | 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. | 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 and 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. It will be reported in units of centimeters. | 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 and 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. It will be reported in units of centimeters. | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. | 
| Change from baseline in shoulder imbalance at all available postoperative timepoints | Shoulder imbalance will be calculated from the Clavicle Angle and PA TL Spine radiograph. Clavicle Angle is defined as the angle between the Clavicle Horizontal Reference Line (CHRL), which is the line drawn perpendicular to the lateral edge of the radiograph that touches the most cephalad portion of the elevated clavicle and the line connecting the margins of the left and right clavicle. A depressed clavicle yields a positive angle, while a right clavicle above the CHRL yields a negative angle. Clavicle Angle is measured in units of degrees and will be used to determine Shoulder Imbalance. | Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. | 
| Individual Subject Success | Main Thoracic Cobb angle is less than or equal to 40 degrees at 24 months following treatment without any secondary spinal surgery defined as treatment failure up to 24 months. | 24 months. | 
| Change from baseline in Pediatric Quality of Life Inventory™ (PedsQL) at all available postoperative timepoints | The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQoL) in children and adolescents and those with acute and chronic health conditions. The 23-item PedsQL Generic Core Scales are designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales are physical functioning, emotional functioning, social functioning and school functioning. The 3 Summary Scores are Total Scale score, Physical Health Summary score, and the Psychosocial Health Summary score. Two versions of this assessment will be filled out, one by the subject and one by the parent or legal guardian. Scores are transformed on a scale from 0-100. Higher score means better outcome. | Baseline to 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. | Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. | 
| Change from baseline in Neurological status at all available postoperative timepoints | Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raising. Neurological change will be defined as deteriorate, maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the baseline evaluation to the time period evaluated. Therefore, if any one element in any section does not stay the same or improve, then a patient will not be considered a success for neurological status. | Baseline, immediately after the surgery, 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. | 3 months. | 
| Number of device or procedure related adverse events up to 24 months | Device or 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 investigational device or procedure. | During surgery to 24 months. | 
| Number of secondary spinal surgeries not defined as treatment failure up to 24 months | CEC adjudication of secondary surgeries will be used for this endpoint. | Immediately after surgery to 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Progressive Scoliosis, BRAIVE, Anterior Vertebral Body Tethering, AVBT, Growth modulation system