Health & Fitness
The Anand Spine Group Enrolls First Patient In TOPS System Study
National FDA Pivotal Study Examining TOPS™ System as Alternative to Lumbar Fusion Surgery
LOS ANGELES, Calif. – The Anand Spine Group in Los Angeles has enrolled the first patient in Los Angeles into the FDA/IDE pivotal study of the TOPS™ System, sponsored by Philadelphia, PA-based Premia Spine, Ltd. The study examines the use of the TOPS™ System following a decompression for the treatment of degenerative Grade I spondylolisthesis and spinal stenosis.
The Anand Spine Group, led by Neel Anand, MD, MCh, Orth, professor of orthopaedic surgery and director of spine trauma at Cedars-Sinai Medical Center, is one of 30 spine centers throughout the U.S. participating in the FDA study to evaluate the efficacy and safety of the TOPS™ System compared to traditional lumbar fusion. The TOPS System is an alternative to rigid fixation with a mechanical implant that allows two adjoining vertebrae to continue moving naturally after a decompression.
“We are very excited to enroll the first TOPS™ System patient in Los Angeles. This study allows us to measure the efficacy of this motion preserving device for the surgical treatment of degenerative spondylolisthesis and spinal stenosis,” said Dr. Anand.
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As part of the study, the 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 the Premia device.
Clinical sites will measure Oswestry Disability Index (ODI), visual analog scale (VAS), neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over five years.
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“There are countless numbers of people suffering from debilitating back pain caused by a slipped disc or narrowing of the spine that must either manage the pain through physical therapy and injections or undergo surgery,” added Dr. Anand. “We hope that this study will provide us the scientific data needed to support the continued use of technologies that aim to correct underlying spinal conditions while helping to restore range of motion.”
Study participants must be experiencing: radiating leg pain, greater leg or buttock pain than back pain, severe pain after walking as little as 100 yards or 2 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 and additional spinal conditions. Patients can learn more about the TOPS System™ study at The Anand Spine Group by calling (310) 423-9779 or visiting www.anandspinegroup.com.
