Zimmer Biomet Holdings, Inc. announced results of a seven-year outcomes study demonstrating statistical superiority of its Mobi-C Cervical Disc Prosthesis versus two-level anterior cervical discectomy and fusion (ACDF) in overall success. In the study, overall success required improvement in Neck Disability Index (NDI), no secondary surgical interventions at the index levels, and absence of major complications defined as radiographic failure, neurological failure or adverse events.
Mobi-C was the first cervical disc prosthesis approved by the US Food and Drug Administration (FDA) for reconstruction of the cervical disc at both one and two levels, to treat severe pain in the neck or arm caused by various spine disorders or injuries. The data presented at the annual meeting of the North American Spine Society (NASS) being held in Boston on October 26 to 29, 2016, one of six Mobi-C podium presentations at NASS.
The prospective, randomized, controlled trial was conducted as an FDA-regulated Investigational Device Exemption (IDE) clinical trial of the Mobi-C Cervical Disc. The trial compared outcomes including NDI, neck and arm pain as measured on the Visual Analog Scale (VAS) and patient satisfaction, between two-level cervical total disc replacement (cTDR) procedures and two-level ACDF procedures, over seven years. The authors conclude that Mobi-C at two contiguous levels continues to demonstrate superiority to ACDF in overall study success rates through 84 months.
"Comparing cTDR and ACDF in this prospective, randomized study with long-term follow-up, Mobi-C showed statistically significant better clinical improvement in general and disease-specific outcome measures compared to ACDF," said Dr. Kris Radcliff, the lead author of the study and Associate Professor in Orthopedic Surgery and Neurosurgery at Thomas Jefferson University. "Further, significantly lower rates of subsequent surgery and adjacent segment degeneration were observed with Mobi-C at seven years."
"Seven-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of two-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter FDA clinical trial" presented in the Anterior Cervical abstracts session on Wednesday, October 26.
"Our seven-year data reinforcing the clinical utility of Mobi-C is not only an important milestone for this revolutionary device, but also further validation of the value of cervical motion preservation technology in treating severe pain in the neck or arm caused by various spine disorders or injuries," said Adam Johnson, Zimmer Biomet's Group President of Spine, Dental, CMF and Thoracic. "Mobi-C represents a critical pillar in establishing Zimmer Biomet as an emerging leader in spine health, and with the growing body of clinical and real-world evidence supporting its efficacy and safety, Mobi-C is poised to become the new standard of care for cervical disc replacement."
Mobi-C was the first cervical disc prosthesis approved by the FDA for reconstruction of the cervical disc at both one and two levels to treat severe pain in the neck or arm caused by various spine disorders or injuries. Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. The company design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.