Board-certified neurosurgeon participates in FDA/IDE study examining use of TOPS™ System
Scott Meyer, MD, a board-certified neurosurgeon for Atlantic Neuroscience Institute, has been selected to participate in a U.S. Food and Drug Administration (FDA)/Investigational Device Exemption (IDE) pivotal study examining the use of Total Posterior Arthroplasty System (TOPS) to treat patients with degenerative Grade I spondylolisthesis or spinal stenosis. The study is sponsored by Premia Spine, Ltd.
TOPS is a screw-based implant that serves as an alternative to traditional spinal fusion. Instead of locking vertebrae together through fusion, the device stabilizes the vertebral segment while still allowing normal motion in all directions.
“This study offers patients who meet the study’s criteria a unique opportunity to potentially receive an innovative new device that may not only help us correct their underlying spinal condition, but also help restore their range of motion,” says Dr. Meyer. “We’re actively enrolling patients at Overlook and Morristown medical centers and encourage anyone who has — or thinks they may have — degenerative spondylolisthesis and spinal stenosis to contact us to learn more about their treatment options.”
Study participants must have degenerative spondylolisthesis, spinal stenosis, and be experiencing radiating leg pain; greater leg or buttock pain than back pain; severe pain after walking as little as 100 yards or two minutes; and/ or pain that reduces when sitting, bending forward, or leaning over a shopping cart. These symptoms could be signs of degenerative spondylolisthesis, spinal stenosis or other spinal conditions.
Patients will either undergo surgery with TOPS or lumbar spinal fusion. Patients are randomly placed into one group or the other with a 67% likelihood of undergoing surgery with TOPS.
TOPS has been commercially available in Europe, the UK, Australia and elsewhere since 2012. This study is part of the process for bringing TOPS to patients in the United States.
Overlook and Morristown medical centers are among 40 spine centers throughout the U.S. taking part in the study.
Jill D., 55, of Hewitt, NJ, had been suffering from back pain for years. After two years of treating her spondylolisthesis medicinally, the pain radiating down her back and legs became unbearable. Thankfully, her sister recommended a consult with Scott A. Meyer, MD, who explained that Jill would be an excellent candidate for the TOPS clinical trial.
Jill, the first patient in NJ to participate in the trial, is now pain-free. "Thanks to Dr. Meyer, I feel like a completely new person.”