Clinical trial NCT04929678: Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Keywords: Juvenile Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Progressive Scoliosis
BRAIVE
Anterior Vertebral Body Tethering
AVBT
Growth modulation system
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
Collaborators: name: Medical Metrics Diagnostics, Inc
First posted: 2021-06-18
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 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

Primary outcomes:
measure: Summary of device-related adverse events up to 24 months
timeFrame: Baseline to 24 months.
Secondary outcomes:
measure: Assessment of procedure-related adverse events up to 24 months
timeFrame: Baseline to 24 months.
measure: Assessment of secondary Spinal surgeries related to the original study device up to 24 months.
timeFrame: Baseline to 24 months and up to skeletal maturity
measure: Assessment of device deficiency up to 24 months
timeFrame: Baseline to 24 months and up to skeletal maturity
measure: Change from baseline in main thoracic Cobb angle at all available postoperative time points
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in proximal thoracic Cobb angle at all available postoperative timepoints
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in thoracolumbar/lumbar Cobb angle at all available postoperative timepoints
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from post-op baseline in Instrumented Cobb Angle at all available postoperative time points.
timeFrame: Immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in thoracic kyphosis at all available postoperative timepoints
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in Lumbar Lordosis at all available postoperative timepoints.
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in coronal balance at all available postoperative timepoints.
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in Sagittal Balance at all available postoperative timepoints
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in total vertical thoracic spine height (T1-T12) at all available postoperative timepoints.
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in total vertical spine height (T1-S1) at all available postoperative timepoints
timeFrame: Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Change from baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at all available postoperative timepoint
timeFrame: Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
measure: Status of return to full activity within 3 months per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
timeFrame: 3 months.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
Study officials:
References: