Further follow-up was recently reported from a prospective multicenter randomized controlled, non-inferiority IDE trial comparing 2-level cervical total disc replacement (TDR) using the Mobi-C artificial disc versus fusion for symptomatic two-level radiculopathy or myeloradiculopathy. 12.8% of patients were lost to follow-up at 48 months. Statistical superiority was maintained for the 2-level TDR group using a composite clinical/radiologic primary endpoint measure of “overall success” that includes the NDI success rate (79.3% versus 53.4%, p < 0.0001) and the need for secondary surgeries (4.0% versus 15.2%, p < 0.0001). Statistically less radiologic adjacent segment pathology was also maintained at 48 months. This ongoing FDA-regulated study continues to present intriguing results that further highlight need for extended follow-up to address TDR-specific concerns regarding heterotopic ossification and disc height loss.
Source
National Center for Biotechnology Information