The Anand Spine Group Selected to Study Use of TOPS System to Treat Back Pain

LOS ANGELES, Calif. – The Anand Spine Group in Los Angeles has received approval to participate in a FDA/IDE pivotal study, sponsored by Philadelphia, PA-based Premia Spine, Ltd., studying the use of the TOPS™ System as potentially the first posterior arthroplasty device 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. 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,” said Dr. Anand.

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.

“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.