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Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)

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ClinicalTrials.gov Identifier: NCT04929678
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : August 27, 2021
Sponsor:
Collaborators:
Exponent, Inc.
Medical College of Wisconsin
Medical Metrics Diagnostics, Inc
Syntactx
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Scoliosis Adolescent Idiopathic Scoliosis Device: Braive™ Growth Modulation System (Braive™ GMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : December 25, 2024
Estimated Study Completion Date : December 25, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Braive™ Growth Modulation System (Braive™ GMS) Device: Braive™ Growth Modulation System (Braive™ GMS)

The Braive™ GMS is designed as a growth-modulation, non-fusion technique, which utilizes patients' remaining growth potential to limit further progression of the curve, to provide correction of the thoracic spine, and allow continued growth while maintaining mobility.

The system consists of the following components: Braid, Fixed Angle Screws (FAS), Plate, and Break-Off Set Screw.





Primary Outcome Measures :
  1. Change in pre-operative Cobb angle compared to the post-operative Cobb angle at 24 months. [ Time Frame: Baseline to 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.

  2. Number of secondary spinal surgeries defined as treatment failure up to 24 months postoperatively [ Time Frame: Immediately after surgery to 24 months. ]
    CEC adjudication of secondary surgeries will be used for this endpoint.


Secondary Outcome Measures :
  1. Change from baseline in Cobb angle at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, and annually until skeletal maturity is reached. ]
    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.

  2. Change from baseline in thoracic kyphosis at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  3. Change from baseline in coronal balance at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  4. Change from baseline in total vertical thoracic spine height (T1-T12) at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  5. Change from baseline in total vertical spine height (T1-S1) at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  6. Change from baseline in shoulder imbalance at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  7. Individual Subject Success [ Time Frame: 24 months. ]
    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.

  8. Change from baseline in Pediatric Quality of Life Inventory™ (PedsQL) at all available postoperative timepoints [ Time Frame: Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  9. Change from baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at all available postoperative timepoint [ Time Frame: Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  10. Change from baseline in Neurological status at all available postoperative timepoints [ Time Frame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. ]
    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.

  11. Status of return to full activity within 3 months per Scoliosis Research Society-22 Patient Questionnaire (SRS-22) [ Time Frame: 3 months. ]
    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.

  12. Number of device or procedure related adverse events up to 24 months [ Time Frame: During surgery 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.

  13. Number of secondary spinal surgeries not defined as treatment failure up to 24 months [ Time Frame: Immediately after surgery to 24 months. ]
    CEC adjudication of secondary surgeries will be used for this endpoint.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • Parent or legal guardian has signed Informed Consent Form and Authorization to Use and Disclose Health Information (if applicable); and patient/participant has signed the Subject Assent Form

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04929678


Contacts
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Contact: Katie Cameron 763-505-9439 katie.cameron@medtronic.com

Locations
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United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Karen Smith       karen.smith3@nhs.net   
Principal Investigator: Andrew Bowey         
Sponsors and Collaborators
Medtronic Spinal and Biologics
Exponent, Inc.
Medical College of Wisconsin
Medical Metrics Diagnostics, Inc
Syntactx
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Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT04929678    
Other Study ID Numbers: MDT19009SD1901
287046 ( Other Identifier: IRAS )
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Medtronic Spinal and Biologics:
Juvenile Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Progressive Scoliosis
BRAIVE
Anterior Vertebral Body Tethering
AVBT
Growth modulation system
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases