News from Eisenhower Desert Orthopedic Center:
National FDA Pivotal Study Examines TOPS™ System: First Posterior Arthroplasty Device for Treatment
of Degenerative Grade I Spondylolisthesis and Spinal Stenosis
Eisenhower Desert Orthopedic Center has received approval to participate in a FDA/IDE pivotal study, sponsored by Premia Spine, Ltd., studying the use of the TOPS™ System. If approved, TOPS would potentially be the first posterior arthroplasty device for the treatment of degenerative Grade I spondylolisthesis and spinal stenosis.
Eisenhower Desert Orthopedic Center is the first in California and one of only 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 that is 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.
“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,” says A. David Tahernia, MD, a Board Certified Orthopedic Surgeon at Eisenhower Desert Orthopedic Center.
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.
“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,” adds Dr. Tahernia. “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 two (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 760-773-4545.
About Eisenhower Health
Eisenhower Health is a not-for-profit, comprehensive health care institution that includes the 463-bed Eisenhower Hospital, the Barbara Sinatra Children’s Center at Eisenhower and the Annenberg Center for Health Sciences at Eisenhower. The Betty Ford Center is also located on the Eisenhower campus. Eisenhower is renowned for its Centers of Excellence in Orthopedics, Cardiovascular, Neuroscience and Oncology. Situated on 130 acres in Rancho Mirage, and with outpatient clinics across the valley, Eisenhower Health has provided a full range of quality medical and educational services for more than 45 years for residents and visitors to the greater Coachella Valley. Eisenhower has earned ANCC Magnet Recognition® for professionalism in nursing and excellence in patient care. The first accredited teaching hospital in the valley, Eisenhower trains physician residents in both Internal Medicine and Family Medicine. For more information, visit EisenhowerHealth.org or follow Eisenhower Health on social media.