SARASOTA – Spinal fusion is generally considered the “gold standard” in the surgical treatment of low-back pain and neck pain with arm pain; however, fusion surgery is often associated with accelerated degeneration and disease in adjacent levels of the spine. This degeneration of the adjacent level has led surgeons to explore non-fusion technologies such as disc replacements.
Led by Orthopedic Spine Surgeon Ashvin Patel, MD, Sarasota Memorial Hospital is testing non-fusion technologies and motion-sparing devices that could change the gold standard.
“With advances in non-fusion techniques and devices, our goal is to decrease or eliminate the pain and stabilize the spine while also preserving functional movement and shortening recovery time,” said Dr. Patel. “These breakthrough devices have shown in early clinical studies to deliver immediate and sustained pain relief and improvement in patient quality of life. We are proud to be among the first to bring these pivotal studies to our community, and more importantly, give patients potential access to new technology not yet commercially available in our country.”
The 2 studies currently enrolling local patients with degenerative spondylolisthesis and spinal stenosis in the lumbar spine or 2-level cervical disc disease include:
Centinel Spine’s SMART study — a motion sparing procedure for patients with two-level cervical disc disease. Approved in Europe and many other countries throughout the world, this nationwide clinical trial is evaluating the safety and effectiveness of prodisc C SK and prodisc C Vivo cervical implants for total disc replacement procedures, compared with an already-approved two-level TDR device called the Mobi-C Cervical Total Disc Replacement. The study is taking place in 30 institutions and slated to enroll up to 600 patients who will be randomly selected to receive either the prodisc C SK, prodisc C Vivo or the control device Mobi-C Cervical Total Disc Replacement. Approximately 20 patients will be enrolled at the SMH study site.
Premia Spine’s TOPS System — a posterior motion preservation system for patients with degenerative lumbar spondylolisthesis and spinal stenosis. Approved in Europe and Australia, this U.S. clinical trial is evaluating the safety and efficacy of TOPS compared to traditional lumbar spinal fusion. Developed to offer a new treatment option for patients suffering from spinal stenosis or spondylolisthesis, TOPS is designed to provide mobility, stability and durability after decompression. TOPS has shown in early clinical studies to deliver immediate and sustained pain relief and improvement in patient quality of life, and is the first and only facet joint replacement system for the lumbar spine. The study is taking place in 30 institutions and slated to enroll 330 patients who will be randomly selected to receive either the TOPS System or lumbar fusion (an interbody cage plus screws and rods). Patients who meet the study criteria have a 67% likelihood of receiving the TOPS device.
While Dr. Patel sees the potential promise in the new motion-sparing techniques, he cautions that they are not for everyone.
“An ideal patient for both studies is one who has more radiating or extremity pain rather than more midline neck or low back pain.” Dr. Patel notes that the ideal patient for the Premia TOPS Lumbar Study should have minimal degeneration of the lumbar disc, as it is not being replaced. The ideal patient for the Centinel Smart Cervical Study should have minimal disease in the facet joint as the facet joint is not being replaced, only the disc.
Dr. Patel also notes that patients with severe osteoporosis are not good candidates for these studies as their bone density is not adequate for the success of the implants. In addition, patients with severe degeneration of the lumbar disc or severe degeneration of the cervical facet joint are not good candidates as these diagnoses are not addressed by the new procedures.
For information on either clinical trial, contact research coordinator Justin Coffeen at 941-365-0655, ext. 344.
About Sarasota Memorial
Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of care, with more than 1 million patient visits each year. Its flagship 839-bed, acute-care hospital has been consistently recognized as one of the nation’s largest and best, with superior patient outcomes and a complete continuum of outpatient services – from urgent care, trauma and emergency services to laboratory and diagnostic imaging, home health, skilled nursing and rehabilitation. SMH is the only hospital in Florida to have consistently earned the federal Centers for Medicare & Medicaid Services’ highest five-star quality award since the rating system launched in 2016.