John Chi, MD, director of neurosurgical spinal oncology at Boston-based Brigham and Women's Hospital, presented the 12-month outcomes data from Spineology's SCOUT clinical trial at the 2018 North American Spine Society Meeting in Los Angeles, Sept. 26-29.
The prospective, multicenter, nonrandomized study evaluated the safety and effectiveness of instrumented lumbar interbody fusion procedures for degenerative disc disease treatment. The study involved Spineology's OptiMesh deployable implant.
Spineology included 102 patients in the study who suffered from lumbar DDD for at least six months. Of the study participants, 80 completed 12-month postoperative follow-ups and 27 completed 24-month follow-ups.
Here are three findings:
1. At the primary fusion endpoint, 93 percent with available films were fused.
2. Approximately 89 percent of study participants reported "excellent" or "good" patient satisfaction at the 12-month follow-up.
3. At the 24-month follow-up, 24 of the 27 patients reported "excellent" or "good" patient satisfaction.
With no unanticipated adverse events and no interbody device-related serious adverse events, Dr. Chi concluded, "We have found this innovative minimally invasive graft contaminant device to be a safe and effective option for lumbar interbody fusion procedures."