Spineology announced that 24-month outcomes from its Scout clinical trial for interbody fusion revealed substantial improvements in scores for low back pain and functional limitations.
The Scout trial was conducted under an FDA-approved investigational device exemption protocol to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for treating degenerative disc disease. Spineology presented the results at last week’s Society for Minimally Invasive Spine Surgery annual meeting in Las Vegas.
The trial used Spineology’s porous graft containment mesh designed to deploy within the disc space, allowing the packed bone graft to conform to the prepared vertebral body endplates. The study observed 102 patients experiencing painful lumbar DDD for at least six months.
Enrollment is complete as 102 patients have been enrolled across 10 sites. Director of neurosurgical spinal oncology at Boston’s Brigham and Women’s Hospital Dr. John Chi reported on 82 patients who completed 24-month follow-ups, observing the back pain and functional limitations were improved according to the Visual Analog Scale and Oswestry Disability Index.
At 24 months, the study yields a fusion rate of 98% and about 90% of subjects reported “excellent” or “good” patient satisfaction at six, 12 and 24 months. No unanticipated adverse events and no interbody device-related serious adverse events were reported.
The study showed similar outcomes compared to its 12-month data, which showed that 100% of subjects examined achieved fusion and 93% of patients at one year reported excellent or good satisfaction with their surgery, with no adverse events occurring.
St. Paul, Minn.–based Spineology’s OptiMesh deployable implant won FDA clearance in 2003 for graft containment within the vertebral body. The company hopes the Scout trial will provide data in support of expanding OptiMesh’s indications to lumbar interbody fusion for treating DDD.
“We have found this innovative minimally invasive graft containment device to be a safe and effective option for lumbar interbody fusion procedures,” Dr. Chi said in a news release. “Patient-reported outcomes are very favorable, including improved function, reduced pain and high satisfaction rates. Combined with excellent safety and radiographic fusion, the Scout study is demonstrating very favorable results.”
“We are very pleased to know that Scout patients have reported highly positive outcomes early on, and these improvements have been maintained or increased over time,” added Spineology CEO John Booth. “We look forward to completing patient follow-up and gaining the clearance that will allow us to market this unique fusion device. We are grateful to Dr. Chi and all the Scout investigators for their commitment to this important clinical trial.”