Zimmer Biomet has 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 was presented at the annual meeting of the North American Spine Society (NASS; 26–29 October, Boston, USA).
The prospective, randomised, 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, randomised 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 Kris Radcliff, the lead author of the study and associate professor in orthopaedic surgery and neurosurgery at Thomas Jefferson University, Philadelphia, USA. “Further, significantly lower rates of subsequent surgery and adjacent segment degeneration were observed with Mobi-C at seven years.”
“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.”