RANCHO MIRAGE – Eisenhower Desert Orthopedic Center has received approval to participate in a Food and Drug Administration/Investigational Device Exemption 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.
The TOPS™ System is an alternative to traditional fusion surgery for patients suffering from moderate to severe lumbar spinal stenosis, with or without spondylolisthesis.
An investigational device exemption allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to the FDA.
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,” Dr. A. David Tahernia, a Board Certified Orthopedic Surgeon at Eisenhower Desert Orthopedic Center, said in a prepared statement.
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,” Tahernia said. “We hope that this study (at Eisenhower Desert Orthopedic Center) 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 at Eisenhower Desert Orthopedic Centermust 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.