Altair Health Neurosurgeon Seeks Patients with Spondylolisthesis and Spinal Stenosis to Enroll in Clinical Trial and Potentially Receive Motion-Preserving Device
Board-certified neurosurgeon participates in FDA/IDE study examining use of TOPS™ System
Dr. Scott Meyer, a board-certified neurosurgeon at Altair Health – one of the nation’s first physician-managed healthcare systems devoted to comprehensive spine care – has been selected to participate in a U.S. Food & Drug Administration (FDA)/Investigational Device Exemption (IDE) pivotal study examining the use of TOPS™ to treat patients with degenerative Grade I spondylolisthesis or spinal stenosis. The study is sponsored by Premia Spine, Ltd.
TOPS™, or Total Posterior Arthroplasty System, 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 our office in Morristown 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 the TOPS™ System or lumbar spinal fusion. Patients are randomly placed into one group or the other with a 67 percent 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 brining TOPS™ to patients in the United States.
Altair Health is one of 30 spine centers throughout the U.S. taking part in the study.
Patients or referring physicians can learn more about the TOPS™ System study at https://premiaspine.com/topstm-system/what-is-tops/ or by calling 833.4ALTAIR (833.425.8247).
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About Altair Health
Altair Health is one of the nation’s first physician-managed healthcare systems devoted to comprehensive spine care. Headquartered in Morristown, NJ, a team of spine specialists – including neurosurgeons, physical therapists, pain management specialists, physiatrists, wellness specialists and more – collaborate and leverage the power of integrated, evidence-based care for improved outcomes. Learn more at AltairHealth.com.