What is the mechanism of action of this treatment?

The most common treatments for Adolescent Idiopathic Scoliosis (AIS) include bracing and surgical interventions. Bracing works by applying external pressure to the spine to halt the progression of curvature, which is crucial for patients who are still growing to prevent severe deformities. Surgical options, such as spinal fusion or growth modulation systems like the Braive™ GMS, physically correct the spinal curvature and guide spinal growth over time. These treatments are essential for managing AIS as they help maintain spinal function and improve quality of life by addressing the structural issues of the spine.

What side effects are associated with this type of intervention?

The Braive™ Growth Modulation System (GMS) and similar treatments for Adolescent Idiopathic Scoliosis generally aim to guide spinal growth and correct curvature. Common side effects of such growth modulation systems can include discomfort at the implantation site, risk of infection, and potential for device-related complications such as hardware failure or migration. Bracing, another common treatment, may cause skin irritation, discomfort, and psychological impact due to the visible nature of the brace. Surgical interventions, such as spinal fusion, carry risks of infection, blood loss, nerve damage, and the need for future surgeries.

What prior FDA approvals exist?

Traditional FDA-approved treatments for Adolescent Idiopathic Scoliosis (AIS) include bracing, such as the Boston Brace, which aims to halt curve progression, and surgical interventions like spinal fusion, which correct and stabilize the spine using rods and screws. These treatments differ from the Braive™ Growth Modulation System (GMS), which is designed to guide spinal growth in pediatric scoliosis, offering a potentially less invasive approach to managing the condition.

What other types of research exist?

Promising novel alternatives to the Braive™ GMS for treating Adolescent Idiopathic Scoliosis in 2024 include: 1) Vertebral Body Tethering (VBT), a minimally invasive surgical technique that uses a flexible cord to correct spinal curvature while allowing growth. 2) ApiFix, a less invasive, motion-preserving device that adjusts the spine using a ratchet mechanism. 3) Magnetic Expansion Control (MAGEC) rods, which are adjustable growth rods controlled magnetically to correct spinal deformities without repeated surgeries.

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Device

Braive™ GMS for Scoliosis (BRAIVE IDE Trial)

N/A

Waitlist Available

Research Sponsored by Medtronic Spinal and Biologics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative

Has a diagnosis of juvenile or adolescent idiopathic scoliosis

Must not have

Has undergone previous spinal fusion procedure(s) at the affected levels

Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the benefits and safety of the Braive™ GMS device in children with worsening scoliosis. The device helps straighten their spine and prevent further curvature.

Who is the study for?

This trial is for children and adolescents with juvenile or adolescent idiopathic scoliosis. They should have a main thoracic Cobb angle of 30-60 degrees, be skeletally immature (Sanders Score of 2-5), and not responded to conservative treatments. Participants must not have had prior chest surgery, spinal abnormalities, severe lung disease, or any condition that could interfere with the study.

What is being tested?

The Braive™ Growth Modulation System (Braive™ GMS) is being tested for its safety and potential benefits in treating progressive pediatric scoliosis. The study will assess how well this system can manage the curvature of the spine in young patients.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions to implant materials such as inflammation or infection at the site of surgery, discomfort from the device itself, and general surgical risks like bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spine curvature is less than or equal to 40 degrees.

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I have been diagnosed with scoliosis since I was a child or teenager.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had spinal fusion surgery at the affected levels.

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I cannot or will not follow up or follow instructions after surgery.

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I am at high risk for infections or have a weak immune system.

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I have had surgery on the same or opposite side of my chest before.

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I have a severe long-term lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Summary of device-related adverse events up to 24 months

Secondary study objectives

Assessment of device deficiency up to 24 months

Assessment of procedure-related adverse events up to 24 months

Assessment of secondary Spinal surgeries related to the original study device up to 24 months.

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Braive™ Growth Modulation System (Braive™ GMS)Experimental Treatment1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Adolescent Idiopathic Scoliosis (AIS) include bracing and surgical interventions. Bracing works by applying external pressure to the spine to halt the progression of curvature, which is crucial for patients who are still growing to prevent severe deformities. Surgical options, such as spinal fusion or growth modulation systems like the Braive™ GMS, physically correct the spinal curvature and guide spinal growth over time. These treatments are essential for managing AIS as they help maintain spinal function and improve quality of life by addressing the structural issues of the spine.