Ashvin Patel, MD, is leading research on motion-preserving and nonfusion technologies at Sarasota (Fla.) Memorial Hospital that could potentially overtake spinal fusion as the standard of care, Florida Trend reported July 15.
Motion-preservation technologies are becoming more prominent in spine surgery as providers seek options less invasive than fusion that can preserve functional movement and reduce recovery time.
"These breakthrough devices have shown in early clinical studies to deliver immediate and sustained pain relief and improvement in patient quality of life," Dr. Patel told the publication. "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."
Sarasota Memorial is enrolling patients with degenerative spondylolisthesis and spinal stenosis in the lumbar spine or two-level cervical disc disease in two clinical trials:
1. Centinel Spine's Smart study is evaluating the safety and effectiveness of Prodisc C SK and Prodisc C Vivo for cervical disc replacement, compared to Zimmer Biomet's Mobi-C device. Thirty institutions are enrolling up to 600 patients, with Sarasota Memorial enrolling about 20 of those patients.
2. Premia Spine's motion-preservation system, Tops, is being evaluated in patients with degenerative lumbar spondylolisthesis and spinal stenosis. Designed to provide mobility, stability and durability after decompression, the device is the only facet joint replacement system for the lumbar spine, according to the report. About 330 patients will be enrolled at 30 institutions across the U.S.
The ideal patient for the Tops study should have minimal degeneration of the lumbar disc, while the ideal patient for the Smart trial should have minimal disease in the facet joint, according to Dr. Patel.