• Richard D Guyer, Hyun Bae, Domagoj Coric, Pierce D Nunley, Michael Musacchio, Rick C Sasso, and Donna D Ohnmeiss.
• Center for Disc Replacement at Texas Back Institute, Plano, Texas.
• Spine. 2024 Aug 23.

Study DesignProspective trial comparing the investigation group to propensity matched historic control group.ObjectiveTo evaluate 5-year results of single-level PEEK-on-ceramic cervical total disc replacement (TDR) compared to a propensity matched anterior cervical discectomy and fusion (ACDF) control group.Summary Of Background DataCervical TDR has gained acceptance as treatment for symptomatic disc degeneration. The design and materials used in these devices continue to evolve.MethodsData were collected in the Food and Drug Administration Investigational Device Exemption trial for the PEEK-on-ceramic Simplify(®) Cervical Artificial Disc (n=150) with comparison to a propensity matched ACDF control group (n=117). All patients were treated for single-level cervical disc degeneration with radiculopathy and/or myelopathy. Clinical outcome was based on composite clinical success (CCS), Neck Disability Index (NDI), visual analog scales (VAS) assessing pain, re-operations, and satisfaction. Radiographic measures included segmental range of motion (ROM), disc space height, and heterotopic ossification (HO). Evaluations were performed pre-operatively and post-operatively within 2 and 6 weeks, and 3, 6, 12 months, and annually thereafter.ResultsAt 5-year follow-up, CCS was significantly greater with TDR than ACDF (91.1% vs. 74.6%; P<0.01). In the TDR group, the mean NDI score was 63.3 pre-operatively, reduced significantly to 23.1 at 6 weeks and remained below 20 throughout 5-year follow-up. In the ACDF group, the mean pre-operative NDI score was 62.4, decreasing to 33.7 at 6 weeks, and ranged from 25.9 to 21.5 throughout follow-up. Mean NDI scores were significantly lower in TDR group at all post-operative points (P<0.05). Mean TDR ROM was 7.3o pre-operatively and 10.1o at 5 years. Bridging HO occurred in 9%. With TDR, there were 6 re-operations (4.0%) vs. 11 (9.4%) with ACDF (P>0.40).ConclusionPEEK-on-ceramic TDR produced significantly improved outcomes maintained throughout 5-year follow-up, were similar or superior to ACDF, supporting TDR in appropriately selected patients.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.

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