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
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.Summary of Results:
BRAIVE™ Growth Modulation System was designed to limit further progression of the Juvenile Idiopathic Scoliosis (JIS)/ Adolescent Idiopathic Scoliosis (AIS) curve, to provide correction of the thoracic spine, and allow continued growth while maintaining mobility. Cobb angle, thoracic kyphosis and lumbar lordosis, and coronal and sagittal balance measurement improvements were noted compared to baseline through at least 12 months and often later timepoints, demonstrating that the BRAIVE™ GMS device fulfilled its design requirements. Subjects were able to return to their normal activities and often had improved Scoliosis Research Society 22 Patient Questionnaire (SRS-22) Total Score improvements compared to baseline.
The primary safety endpoint was device-related Adverse Events up to 24-months post-operation based on Investigator assessment and Medtronic’s classification. Five events occurred in four subjects, with three events classified as Serious Adverse Events. Three secondary surgeries occurred during the study, which were deemed treatment failures, in addition to two secondary surgeries that occurred after the subjects exited the study. A Unanticipated Serious Adverse Device Effect (USADE) was noted due to the number of subsequent spinal secondary surgeries (4 subjects in January 2025) in the study compared to literature for other Anterior Vertebral Body Tethering (AVBT) devices.
Overall neurological success was observed in all subjects. The mitigated results and under-correction may be explained by several factors. First, surgeons reported that the tensioner was difficult to use, making it challenging to appropriately tension the cord. In addition, the tether design may not have been optimal, as the cord diameter was much smaller than that of other available Vertebral Body Tethering (VBT) systems. Then, the set screw–cord interface may have contributed to fraying of the cord. Lastly, patient selection may have been a consideration, as the device appears to result in under-correction particularly in children with less remaining growth. Medtronic had already decided to end the BRAIVE™ GMS program due to business decisions before the final statistical analysis was performed. The device was investigational in the United States and Canada and therefore no further regulatory approvals will be pursued.The results up to the 24-month follow-up visits have been published earlier and are publicly available, however recently we submitted amended overall results available form the study. These amended results are currently under review as they must be approved before updated publication on ClinicalTrials.gov registry.
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