The Spine Center at Dignity Health St. Mary’s Medical Center (San Francisco, USA), has been selected to participate in a FDA/IDE pivotal study, sponsored by Premia Spine, studying the use of the Tops System. St. Mary’s Medical Center is one of 30 spine centres throughout the USA 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 James Zucherman, orthopaedic 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% 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 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 two minutes,
- and/or pain that reduces when sitting, bending forward, or leaning over a shopping cart.