SAN FRANCISCO, CA (September 5, 2018) – The Spine Center at Dignity Health St. Mary’s Medical Center, has been selected to participate in a FDA/IDE pivotal study, sponsored by Premia Spine, Ltd., studying the use of the TOPS™ System. St. Mary’s Medical Center is one of 30 spine centers throughout the U.S. taking part in the study to evaluate the efficacy and safety of the TOPS™ System compared to traditional lumbar fusion.
The TOPS™ System is a mechanical device designed to restore motion of the spine in all directions. Instead of permanently locking the two vertebrae with a fusion, the device allows the two vertebrae to continue moving. If approved, TOPS™ would potentially be the first posterior arthroplasty device for the treatment of degenerative Grade I spondylolisthesis and spinal stenosis.
“We are very excited to be selected as investigators in the TOPS™ System study because it offers a unique opportunity for patients who meet the study’s criteria to potentially receive a motion-preserving device for the surgical treatment of degenerative spondylolisthesis and spinal stenosis,” said Dr. James Zucherman, orthopedic surgeon and medical director of the St. Mary’s Spine Center.
Patients participating in the study 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.
“There are countless people suffering from debilitating back pain caused by a slipped disc or narrowing of the spine who must either manage the pain through physical therapy and injections or undergo surgery,” added Dr. Zucherman. “We believe 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 by calling (415) 750-5836 or visiting http://www.ClinicalTrials.gov, search (CT0) 301-2776.
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About Dignity Health St. Mary’s Medical Center
Dignity Health St. Mary's Medical Center is an accredited, not-for-profit community hospital that has been caring for the people of San Francisco since 1857. Located across from Golden Gate Park, it is the longest continually running hospital in San Francisco. For three consecutive years, from 2014 to 2016, St. Mary’s received the Distinguished Hospital Award for Clinical Excellence from Healthgrades. St. Mary’s also was recognized as one of the Top 100 Orthopedic Programs nationally by Becker’s Hospital Review and is a Certified Stroke Center by the Joint Commission. St. Mary’s state-of-the-art Cancer Center offers the full-range of oncology, radiation, and imaging services. Offering the most comprehensive breast imaging services in San Francisco, St. Mary’s has been designated as a Center of Excellence by the American College of Radiology, a recognition that represents the national gold standard. For more information, call (415) 668-1000.
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