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Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
Sponsor: Medtronic Spinal and Biologics
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2021-08-12
Completion Date
2026-01-14
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
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.
Locations (4)
Mayo Clinic
Rochester, Minnesota, United States
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom