Mobi-C®, First Artificial Cervical Disc Approved for Two-Level Arthroplasty, Shown in Studies To Have Better Long-Term Results Than Cervical Fusion
Online PR News – 07-January-2014 –Matthew B. Kern, M.D., F.A.A.N.S., a leading Long Island neurosurgeon affiliated with Neurological Surgery, P.C., is among the first metro New York-area surgeons to be certified to implant the new Mobi-C® Disc, the first artificial spinal disc that can be implanted at two adjacent levels of the cervical spine (neck). The device, which can also be used for single-level disc replacement, was approved by the FDA in August 2013 and studied in a large multicenter clinical trial, the results of which were published in the November 2013 Journal of Neurosurgery: Spine.
Unlike spinal fusion – the standard procedure for many patients who have Degenerative disc disease that affects two contiguous (adjacent) damaged discs ––implantation of this artificial disc doesn’t just relieve pain but allows for good postoperative range of neck motion and is less likely than fusion to cause degeneration of surrounding discs. Degenerative disc disease in this region often causes neck pain and pain that radiates down the arm (radiculopathy).
“This new artificial disc represents a leap forward in treating patients with certain types of cervical spine disease,” says Dr. Kern. “It is very common for patients with radiculopathy to have cervical disc degeneration at two levels, and if they meet the criteria for this procedure, it offers a good alternative that may give them better results with fewer long-term complications than fusion.”
The Mobi-C is implanted to replace two adjacent damaged discs in the cervical spine, from levels C3-C7. The device is made for people who have not responded to non-surgical care, and have damaged discs that may or may not cause neck pain, but cause loss of feeling, loss of movement, pain, weakness or tingling down the arm (and possibly into the hand). Surgery with Mobi-C can help keep neck movement – forward-to-back, side-to-side and left-to-right – while reducing pain and tingling caused by the damaged discs.
In the published 330-patient clinical study comparing total disc replacement (TDR) at two levels using Mobi-C and anterior cervical discectomy with fusion (ACDF, disc removal combined with vertebral fusion using bone grafts and metal plates), close to 68% of Mobi-C patients had overall success after two years, compared to approximately 37% of fusion patients. Nearly 96% of Mobi-C patients had four or more degrees of motion while bending the head forward to backward, and the rate of major complications was less than half that of fusion patients. More than three times as many fusion patients (11.4%) needed a second surgery at the treated level as Mobi-C patients (3.1%).
Although just approved in the U.S., Mobi-C has been in use since 2004 in 24 European nations, where more than 17,000 Mobi-C discs have been implanted.
“While other artificial discs have been on the market in the U.S. for a number of years, this is the first time we have a disc that can be implanted at two levels,” says Dr. Kern.
Cervical total disc replacement using artificial discs is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion has been the standard treatment for these indications since the procedure was first developed in the 1950s.
In the published study, 225 patients received the Mobi-C TDR device and 105 patients received ACDF. On average, patients in both groups showed significant improvements in the Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from the preoperative baseline to each time point. The Mobi-C patients, however, experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the Mobi-C group also maintained preoperative range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. At 24 months, Mobi-C demonstrated statistical superiority over ACDF based on overall study success rates.
Dr. Kern is a board certified neurosurgeon. He is skilled in general neurosurgery and specializes in complex spinal procedures, the surgical treatment of brain tumors, as well as the treatment of traumatic injuries to the brain, spine and spinal cord. He has special expertise in minimally invasive procedures and artificial cervical and lumbar disc arthroplasty. He also performs dorsal column stimulation and peripheral nerve surgery such as carpal and cubital tunnel releases.
About Neurological Surgery, P.C. - Neurological Surgery, P.C. is one of the New York City area’s premier neurosurgical groups, offering patients the most advanced treatments of brain and spine disorders. These include minimally invasive procedures such as stereotactic radiosurgery (Gamma Knife®, CyberKnife® and Novalis Tx®), aneurysm coiling, neuro-endoscopy, spinal stimulators, carotid stents, interventional pain management, microdiscectomy, kyphoplasty, and other types of minimally invasive spine surgery. The practice’s physicians represent a range of surgical and nonsurgical specialties, combining compassionate care with highly specialized training. They are leaders in the region’s medical community, with appointments as chiefs of neurosurgery in some of Long Island’s best hospitals. NSPC offers 10 convenient locations in Nassau and Suffolk Counties, as well as in Queens and Manhattan. For more information, call 1-855-263-0000 or visit www.NSPC.com.