Two St. Vincent Charity Medical Center surgeons are participating in a nationwide clinical trial investigating the safety and effectiveness of two new total disc replacement devices intended for the treatment of two-level cervical disc disease.
“Cervical disc replacement implants have been proven to be a safe and effective treatment for many patients experiencing one-level disc disease, avoiding fusion and allowing for more natural neck motion compared to cervical fusion,” Dr. Robert McLain, the principal investigator for the study at St. Vincent Charity, said in a news release. “However, most products on the market do not allow for use in patients with two-level cervical disc disease. This study will evaluate the effectiveness of these two new implants to provide relief for the millions of Americans suffering from multi-level degenerative disc disease.”
Neck pain ranks in the top five disorders in the United States, with 30% to 50% of people reporting incidents of neck pain. While the majority of acute symptoms will resolve with nonoperative or conservative treatments, nearly 30% of those with neck pain will develop chronic symptoms.
The prodisc products being used in the trial are built on the prodisc technology platform, the most widely used total disc replacement system in the world, according to the release. No other disc replacement system has been studied more, with more than 13,000 patients reported on in more than 540 articles over the last 30 years and more than 125,000 prodisc devices have been implanted worldwide, with a reported re-operation rate of less than 1%, the release said.
“Our selection as the only hospital in Cleveland and the state of Ohio to participate in this study furthers St. Vincent Charity’s Spine and Orthopedic Institute’s reputation as a leader in health care excellence and cutting edge sophistication,” said Dr. James Anderson in the release.
The study currently includes 21 sites in 15 states across the country, with an expected primary completion date of spring 2023.
About 20 patients will be included in the study at St. Vincent. Patients between 18 and 69 years of age, suffering from neck and arm pain due to cervical disc disease who have not responded to nonoperative treatment will be considered for the study.
Those interested in participating, should contact Jayson Zadzilka at 330-205-1334 or firstname.lastname@example.org.