Braive™ GMS for Scoliosis

(BRAIVE IDE Trial)

Recruiting at 7 trial locations

Overseen By Katie Cameron

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Spinal and Biologics

Disqualifiers: Non-idiopathic scoliosis, Pregnancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-surgery to 24 months

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the Braive™ Growth Modulation System (Braive™ GMS) treatment for scoliosis?

Research shows that a growth modulation system, similar to Braive™ GMS, helped 3 out of 6 patients with scoliosis by reducing the risk of their spine curving further compared to predictions if they were untreated. This suggests that the treatment may be beneficial in managing scoliosis progression. ^{1 2 3 4 5}

Is the Braive™ Growth Modulation System safe for humans?

The Braive™ Growth Modulation System has been studied in early adolescent idiopathic scoliosis patients, and while the studies focus on effectiveness, they also provide safety insights. In a pilot study, the system was used in six patients, and no specific safety issues were reported. However, as with any surgical procedure, there may be risks, and further studies are needed to confirm long-term safety. ^{1 2 6 7 8}

How is the Braive™ Growth Modulation System treatment different from other scoliosis treatments?

The Braive™ Growth Modulation System is unique because it uses a titanium implant to modulate spine growth, offering an alternative to traditional bracing or observation. This system is designed to reduce the risk of curve progression in scoliosis patients, particularly those who are highly skeletally immature, by providing a corrective force that encourages proper spinal alignment. ^{1 2 7 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Has a main thoracic Cobb angle between 30 and 60 degrees

Is skeletally immature with a Sanders Score of ≥2 to ≤5

Has a Lenke Classification of 1A, 1B, or 1C

Exclusion Criteria

Has an associated syndrome

Has a history of malignant hyperthermia

Has any type of non-idiopathic scoliosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Braive™ Growth Modulation System for the treatment of pediatric progressive scoliosis

Immediate post-surgery to 24 months

Regular follow-up visits at 3, 6, 12, 18, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in spinal measurements

24 months and annually until skeletal maturity

Annual visits until skeletal maturity

Treatment Details

Interventions

• Braive™ Growth Modulation System (Braive™ GMS)

Trial Overview 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.

Participant Groups

Group I: Braive™ Growth Modulation System (Braive™ GMS) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Recruited

10,600+

Exponent, Inc.

Collaborator

Trials

2

Recruited

210+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Medical Metrics Diagnostics, Inc

Industry Sponsor

Trials

14

Recruited

1,800+

Syntactx

Collaborator

Trials

23

Recruited

1,147,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Prospective US FDA IDE Pilot Study of Titanium Clip-Screw Implant at Two to Five Years. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Spine growth modulation with titanium implant: comparisons to observation and bracing in early adolescent idiopathic scoliosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of early-onset scoliosis with a hybrid of a concave magnetic driver (magnetic controlled growth rod) and a contralateral passive sliding rod construct with apical control: preliminary report on 17 cases. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Maintenance of curve correction and unplanned return to the operating room with magnetically controlled growing rods: a cohort of 24 patients with follow-up between 2 and 7 years. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Traditional versus magnetically controlled growing rods in early onset scoliosis surgical treatment. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Systematic review of the complications associated with magnetically controlled growing rods for the treatment of early onset scoliosis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Surgical Treatment of Adolescent Idiopathic Scoliosis with the ApiFix Minimal Invasive Dynamic Correction System-A Preliminary Report of a 24-Month Follow-Up. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Spring distraction system for dynamic growth guidance of early onset scoliosis: two-year prospective follow-up of 24 patients. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Early experience of MAGEC magnetic growing rods in the treatment of early onset scoliosis. [2022]