P106. Disc to Disc: early results of the multicenter, prospective, randomized clinical investigational device exemption trial comparing a novel total disc replacement (TDR) to an approved TDR control at two contiguous levels of the cervical spine

• Published in: The spine journal Vol. 24; no. 9; p. S114
• Main Author: Abjornson, Celeste
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.09.2024
• ISSN: 1529-9430
• DOI: 10.1016/j.spinee.2024.06.128

Previous Investigational Device Exemption (IDE) clinical trials for the treatment of Symptomatic Cervical Disc Disease (SCDD) at two contiguous levels have Compared Total Disc Replacement (cTDR) to Anterior Cervical Discectomy and Fusion (ACDF). These trials have shown superiority of cTDR to ACDF with regards to lower reoperation rates, improvement in Neck Disability Index (NDI), and lower incidence of Adjacent Segment Degeneration (ASD). As cTDR becomes a more established surgical option, the focus has shifted to understanding the performance of different motion sparing technology platforms. To compare the composite clinical success of the control, Mobi-C (ZimVie, Westminster, CO), to the investigational prodisc C Vivo or prodisc C SK (Centinel Spine®, West Chester, PA) at 24 months follow-up. Prospective, Randomized, Multi-Center Controlled IDE Clinical Trial. A total of 433 patients at 35 sites. N/A Under Institutional Review Board approval, randomization was in a 2:1 (investigational: control) ratio with Mobi-C as the control in a noninferiority study design. If randomized to investigational, surgeons were permitted to intra-operatively choose the endplate configuration of prodisc C Vivo or prodisc C SK based on patient anatomy. Based on an adaptive Bayesian model, the first analysis of the data can be reported at 50% of subjects reaching 24-month follow-up. The primary endpoint was composite clinical success (CCS) at 24 months where a patient must be a success in all 4 criteria, defined as: ≥ 15 point improvement in Neck Disability Index (NDI) Score (out of 100) in subjects at 24 months compared with baseline, maintenance or improvement in neurological status at 24 months compared to baseline, no secondary surgical interventions at the index levels, and absence of major device-related adverse events. At 24 months, the CCS was achieved in 87.5% of the prodisc C group compared to 78.6% of the Mobi-C group (95% confidence interval: 5.4 to 12.3; p > 0.99) confirming noninferiority of prodisc C to Mobi-C at two levels. There was no statistical difference in NDI success, major device-related adverse events, or neurological status. There was a higher incidence of secondary surgical interventions in Mobi-C compared to prodisc C, however not statistically different. This is the first randomized study comparing two cervical disc designs. At 24 months, the prodisc C group was as safe and effective as the control at two levels. The Mobi-C group results are consistent with the previous IDE Mobi-C clinical trial results. Further, cervical TDR is consistently a successful surgical option for the treatment of SCDD when conservative treatment has failed. prodisc vivo (Investigational/Not Approved).