Spineology has announced that enrollment is now complete in the company’s Spineology Clinical Outcomes Trial (SCOUT) clinical trial.
The SCOUT IDE, conducted under an FDA-approved protocol, is a prospective, multicentre non-randomised 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.
Spineology’s OptiMesh deployable graft containment implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data to support a regulatory submission for expanded indications, allowing the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful degenerative disc disease.
Stéphane Lavoie (DeLand, USA) enrolled the first SCOUT subject. As one of the top enrolling sites, Lavoie also enrolled the final study subject. He comments, “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.”
Martin King (University of Vermont Larner College of Medicine, USA) adds, “The uniquely deployable mesh allows me to create a confirming bone graft pack to support new bone growth. 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.”
Early results in the SCOUT trial have been encouraging. John Chi (Department of Neurosurgical Spinal Oncology, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA) will formally present interim SCOUT results at the upcoming meeting of the International Society for the Advancement of Spine Surgery (ISASS) this April.