Boulder Neurosurgical & Spine Associates (BNA) and the Justin Parker Neurological Institute (JPNI) are among approximately 30 sites in the U.S. participating in the ACADIA clinical trial. The trial seeks to evaluate the safety and efficacy of the ACADIA Facet Replacement System, an investigational device for treatment of lumbar spinal stenosis (LSS).
In standard decompression surgery with fusion, the vertebrae are fused together after the spinal cord and neural elements are decompressed. This device is designed to replace degenerated facet joints while restoring normal stability and motion in the lumbar spine.
In LSS, the spinal canal narrows and causes pressure on the spinal cord and nerves, resulting in back and leg pain. According to the American Association of Orthopaedic Surgeons (AAOS), an estimated 8% to 11% of the U.S. population suffers from LSS. This condition affects the middle-aged and elderly population and is the most common indication for surgery in patients over age 60. As baby boomers age, an estimated 2.4 million Americans will be affected by LSS by 2021.
"We carefully consider this surgery for our patients after an extensive course of medications, physical therapy, injections and other means of conservative care have failed," said Alan Villavicencio, M.D., Principal Investigator. "The ACADIA Facet Replacement System includes implants that mimic the natural facet joints in the lumbar spine to allow motion, so the potential benefit of this treatment may include lower risk of degeneration at the adjacent spinal levels. All study-related care will be provided at no cost to the qualifying patients."