BRAIVE-IDE study
Research type
Research Study
Full 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 (BRAIVE IDE Study)
IRAS ID
287046
Contact name
Andrew James Bowey
Contact email
Sponsor organisation
Medtronic
Duration of Study in the UK
8 years, 0 months, 5 days
Research summary
The purpose of this study is to evaluate the Braive™ Growth Modulation System (GMS)(or “Study Device”) to see if it is safe and beneficial when used in the treatment of juvenile or adolescent idiopathic scoliosis. This is a rare condition where the spine develops an abnormal curve.
The Braive GMS uses growth modulation by restraining one side of the spine to allow growth on the other side, by placing screws on the outside of the vertebrae that is causing the scoliosis. This device is intended for patients with less severe spine curvature with the potential to grow. The Braive GMS is intended to limit further progression of the curve, to provide correction of the thoracic spine, and allow continued growth while maintaining (spinal) mobility (or flexibility).
The purpose of this study is to establish probable benefit and evaluate the safety and preliminary effectiveness of the Braive GMS as an alternative to treatments for patients who have failed conservative care and for this reason no control group is needed for this study, this is a multi-centre, single arm study. The baseline measurements will be collected prior to implantation of the device and compared against the measurements collected postoperatively. Data will be evaluated for safety and preliminary effectiveness, per the primary objective, at 24 months. The patients will continue to be followed yearly through skeletal maturity.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0300
Date of REC Opinion
4 Jan 2021
REC opinion
Further Information Favourable Opinion