Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis

NCT04929678 | Terminated Results FDA Device

• 2 other identifiers: MDT19009SD1901287046
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 4

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.

Conditions

Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis

Keywords

Juvenile Idiopathic Scoliosis; Adolescent Idiopathic Scoliosis; Progressive Scoliosis; BRAIVE; Anterior Vertebral Body Tethering; AVBT; Growth modulation system

Outcome Measures

Primary Outcomes (1)

• Summary of Device-related Adverse Events up to 24 Months

  Device 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 medical device whether anticipated or unanticipated. Summary will be based on both Investigators and Medtronic relatedness assessment.

  Implanted surgery to 24 months

Secondary Outcomes (15)

• Assessment of Procedure-related Adverse Events up to 24 Months

  Implanted surgery to 24 months

• Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.

  Implanted surgery to 24 months

• Assessment of Device Deficiency up to 24 Months

  Implanted surgery to 24 months

• Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points

  Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months

• Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints

  Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months

Study Arms (1)

Braive™ Growth Modulation System (Braive™ GMS)

EXPERIMENTAL

Device: Braive™ Growth Modulation System (Braive™ GMS)

Interventions

Braive™ Growth Modulation System (Braive™ GMS) 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.

Braive™ Growth Modulation System (Braive™ GMS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Limitations and Caveats

Enrollment was discontinued in March 2023, resulting in only 10 patients treated and followed for up to 24 months (primary endpoint). Treatment patients were then to be followed until Skeletal Maturity, but the decision was made to early terminate the study in November 2025, and all patients exited the study in January 2026. The small sample size limits the ability to draw statistically meaningful conclusions, and there is no plan to seek regulatory approval.

Results Point of Contact

• Title: Irene Ayer
• Organization: Medtronic

irene.ayer@medtronic.com

+41 79 483 64 38

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 18, 2021
• Study Start: August 12, 2021
• Primary Completion: April 11, 2025
• Study Completion: January 14, 2026
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (1); GB (1)