Results were reported from a prospective multicenter randomized controlled IDE non-inferiority trial comparing 2-level cervical total disc replacement (TDR) using the Mobi-C artificial disc (LDR Medical) with fusion for symptomatic two-level radiculopathy or myeloradiculopathy. This is the first 2-level FDA-regulated TDR study and addresses the increasing incidence of multilevel degenerative cervical stenosis in aging populations. Twenty-four clinical sites enrolled 330 patients with contiguous 2-level symptomatic disease in a 2:1 ratio of TDR versus fusion with allograft/plate. 3% of patients were lost at 24 months followup. Statistical superiority was demonstrated for the 2-level TDR group using a composite primary endpoint measure of ‘overall success’ (NDI, secondary surgeries, neurological status, radiographic success, and adverse events). Statistically less radiologic adjacent segment pathology was also observed at 24 months. These results are intriguing and highlight the need for longer-term follow-up to address unanswered questions including chronic polyethylene wear and disc height loss.
Journal of Neurosurgery