Per Florida Trend:
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 two studies currently enrolling local patients with degenerative spondylolisthesis and spinal stenosis in the lumbar spine or two-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.