Zimmer Biomet has announced results of a seven-year outcomes study demonstrating statistical superiority of its Mobi-C cervical disc prosthesis vs two-level anterior cervical discectomy and fusion (ACDF) in overall success. In the study, overall success required improvement in Neck Disability Index, no secondary surgical interventions at the index levels, and absence of major complications defined as radiographic failure, neurological failure or adverse events. The data was presented at the annual meeting of the North American Spine Society (NASS; Boston, USA).
The prospective, randomised, controlled trial was conducted as an FDA-regulated Investigational Device Exemption clinical trial of the Mobi-C cervical disc. The trial compared outcomes including Neck Disability Index, neck and arm pain as measured on the Visual Analog Scale 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,” says Kris Radcliff, the lead author of the study and associate professor in Orthopedic 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.”