Disc to Disc: Two-Year Results of the Multi-Center, 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

Document Type

Conference Proceeding

Publication Date

10-2025

Publication Title

Brain and Spine

Abstract

Introduction 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. Materials and Methods Under Institutional Review Board approval, randomization was in a 2:1 (investigational: control) ratio in a non-inferiority study design. If randomized to investigational, surgeons were permitted to intra-operatively choose the endplate configuration. 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. Results At 24 months, the CCS was achieved in 87.5% of the investigational compared to 78.6% of the control group (95% confidence interval: 5.4 to 12.3; p > 0.99) confirming non-inferiority. 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 control compared to investigational, however not statistically different. Conclusion This is the first randomized study comparing two cervical disc designs. Further, cervical TDR is consistently a successful surgical option for the treatment of SCDD when conservative treatment has failed.

Volume

5

Issue

Suppl 3

First Page

42

Comments

Eurospine (Spine Society of Europe) 2025 Annual Meeting, October 22-24, 2025, Copenhagen, Denmark

Last Page

42

DOI

10.1016/j.bas.2025.104484

Link to Full Text

Share

COinS