John Chi, MD, presented 12-month outcomes data from Spineology's SCOUT clinical trial.
Dr. Chi serves as a neurosurgery associate professor at Harvard Medical School and director of neurosurgical spinal oncology at Brigham and Women's Hospital, both located in Boston.
Here are six things to know.
1. An investigational device exemption study, SCOUT sought to assess safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for degenerative disc disease treatment. The study investigated Spineology's OptiMesh, a porous graft containment mesh.
2. SCOUT involves 102 patients who have suffered from lumbar degenerative disc disease for at least six months. Dr. Chi’s report focused on 84 patients, with 60 completed six-month follow-up and 29 completing 12-month follow-up.
3. Researchers found statistically significant improvements for low back pain and functional limitation scores at six months and 12 months.
4. At 12-months, 100 percent of the patients experienced fusion. Ninety-seven percent of the patients reported "excellent" or "good" satisfaction with their surgery.
5. The study didn't reveal any serious device-related adverse events.
6. Dr. Chi presented the findings at the International Society for the Advancement of Spine Surgery annual meeting in Toronto, Canada.