Centinel Spine in the News: Clinical Trial to Test Replacement Devices for Two-Level Symptomatic Cervical Disc Disease
Source: Hospital For Special Surgery via PR Newswire
A multicenter, prospective, randomized controlled trial is designed to assess the effectiveness of three different disc replacement devices used for two-level symptomatic cervical disc disease. The study is sponsored by Centinel Spine, LLC, and Hospital for Special Surgery (HSS) in New York City, is one of the centers participating in the research.
Cervical disc disease, or degenerative disc disease, is the progressive deterioration of spinal discs and arthritic changes in the facet joints. During this procedure, surgeons will test the safety and efficacy of removing discs at two levels and implanting an artificial disc device at each level of the cervical spine between the vertebrae where the disc was removed. The artificial disc will serve to stabilize the spine while preserving greater motion than a conventional fusion surgery.
Previous patients who underwent artificial disc replacement reported greater improvements in their pain relief, mobility, and activities of daily living than those who underwent spinal fusion surgery, the standard treatment. It is less invasive but as effective as spinal fusion surgery, however the procedure using this particular device has not been validated through a clinical trial to date.
“The concern with doing a fusion type operation is that over the long term the other discs have to accommodate for the motion lost at the fused level,” said Darren Lebl, MD, a minimally invasive spine surgeon who is leading the research at HSS. Over time, the increased mechanical demand on the surrounding vertebrae can make the discs in the region more vulnerable to additional degeneration.
“We do know very clearly that fusion is limiting motion,” Dr. Lebl added. “The concept of the two-level disc replacement is to preserve motion with two moving mechanical devices.”
To be eligible for participation, patients must be between the ages of 18 and 69 years and have received a diagnosis of radiculopathy (impingement of the nerves in the spinal column) or myelopathy with radiculopathy, a more severe form of damage to the spinal cord involving vertebrae in the neck, defined at cervical discs C3 through C7. Patients must also be experiencing symptoms associated with disc problems, such as neck or arm pain, decreased muscle strength and abnormal reflexes that has not responded well to conservative treatments such as rest, heat, physical therapy and pain relievers.
The trial will include at least 390 patients once enrollment is complete. Patients will receive regular evaluations for two years after surgery and may be examined in periodical follow-up visits for a total of seven years.
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Important Note: The patient information presented is for general education purposes only. As with any spine surgery, there are potential benefits, complications, and risks associated with disc replacement and spinal fusion procedures. Individual results may vary. It is important that you discuss the possible risks and potential benefits of various procedures with your doctor prior to receiving treatment, and that you rely on your physician’s best judgment. Only your doctor can determine whether you are a suitable candidate for a specific surgical procedure.
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