Relievant Medsystems released results of the Level I Intracept Study comparing the Intracept Procedure to non-surgical care for chronic lower back pain in The Spine Journal.
Three takeaways:
1. The Independent Data Management Committee recommended the trial halt enrollment early and cross-over the control arm patients due to statistically superior outcomes in patients undergoing the Intracept Procedure.
2. The study analyzed 104 patients — 51 in the Intracept arm and 53 in the standard care arm.
3. Intracept patients showed a 20.9 point greater increase in Oswestry Disability Index compared to standard care for the primary endpoint of mean reduction baseline to three months.
"Patients with chronic low back pain have limited options beyond standard conservative care. These results confirm that the Intracept Procedure is a highly effective new treatment option for these patients," said Jad Khalil, MD, an orthopedic spine surgeon at William Beaumont Hospital in Royal Oak, Mich.
Access the full publication here.