Spineology finishes enrollment in IDE Trial for Mesh Fusion Transplant
Spineology is exhilarated to declare that enrollment stands complete in the SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease
Spineology’s deployable graft containment mesh implant is a uniquely porous device that deploys within the disc space as it is filled, permitting the contained bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.
Dr. Stéphane Lavoie of DeLand, Florida enrolled the first SCOUT subject. As one of the top enrolling sites, Dr. Lavoie also enrolled the final study subject said “The Spineology interbody fusion system allows me to efficiently prepare the disc space for fusion through a very small access, reducing surgical time and trauma to the surrounding tissues. It has been exciting to participate in the clinical trial for this unique fusion system and I have been pleased with my patient outcomes.”
Dr. Martin Krag, Professor of Orthopaedics at the University of Vermont Larner College of Medicine said “Importantly, patient satisfaction is very good. At our institution we have observed rapid and substantial improvements in pain and function scores for study subjects post-surgery.”
Dr. John Chi will be formally presenting interim SCOUT results at the upcoming meeting of the International Society for the Advancement of Spine Surgery (ISASS) to be held this April in Toronto, Canada. Dr. Chi is an Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital, the top enrolling site in the SCOUT IDE trial.
The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients will be followed for 24 months minimum and the company is gathering data on hospital parameters, pain and function, patient satisfaction, safety and radiographic fusion. The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others.