Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2029-12-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Juvenile Idiopathic Scoliosis Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Braive™ Growth Modulation System (Braive™ GMS)

Group Type EXPERIMENTAL

Braive™ Growth Modulation System (Braive™ GMS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No