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Research ArticleTotal Disc Replacement

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up

Richard D. Guyer, Domagoj Coric, Pierce D. Nunley, Rick C. Sasso, Michael Musacchio, Hyun W. Bae, John H. Peloza and Donna D. Ohnmeiss
International Journal of Spine Surgery July 2021, 8084; DOI: https://doi.org/10.14444/8084
Richard D. Guyer
1Center for Disc Replacement at Texas Back Institute, Plano, Texas
MD
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Domagoj Coric
2Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina
MD
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Pierce D. Nunley
3Spine Institute of Louisiana, Shreveport, Louisiana
MD
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Rick C. Sasso
4Indiana Spine Group, Carmel, Indiana
MD
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Michael Musacchio
5NorthShore University Health System, Evanston, Illinois
MD
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Hyun W. Bae
6The Spine Institute, Los Angeles, California
MD
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John H. Peloza
7Steadman-Hawkins Clinic, Vail, Colorado
MD
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Donna D. Ohnmeiss
1Center for Disc Replacement at Texas Back Institute, Plano, Texas
8Texas Back Institute Research Foundation, Plano, Texas
DrMed
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ABSTRACT

Background Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration.

Methods This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n = 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI.

Results The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; P < .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation.

Conclusions The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration.

Clinical Relevance This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion.

Level of Evidence 2.

  • disc replacement
  • cervical spine
  • FDA IDE trial
  • PEEK-on-ceramic device
  • clinical outcome

Footnotes

  • Disclosures and COI: Guyer: Consulting: Simplify; Peloza: Speaking and/or Teaching Arrangements: Simplify Medical; Sasso: Research Support (paid directly to institution/employer) Simplify; Coric, Nunley, Musacchio, Bae, and Ohnmeiss: nothing to disclose.

  • This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2021 ISASS
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International Journal of Spine Surgery
Vol. 19, Issue 3
1 Jun 2025
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Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up
Richard D. Guyer, Domagoj Coric, Pierce D. Nunley, Rick C. Sasso, Michael Musacchio, Hyun W. Bae, John H. Peloza, Donna D. Ohnmeiss
International Journal of Spine Surgery Jul 2021, 8084; DOI: 10.14444/8084

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Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up
Richard D. Guyer, Domagoj Coric, Pierce D. Nunley, Rick C. Sasso, Michael Musacchio, Hyun W. Bae, John H. Peloza, Donna D. Ohnmeiss
International Journal of Spine Surgery Jul 2021, 8084; DOI: 10.14444/8084
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  • Single-Level Total Disc Replacement: Mid- to Long-Term Outcomes
  • Single-Level Total Disc Replacement: Index-Level and Adjacent-Level Revision Surgery Incidence, Characteristics, and Outcomes
  • Anterior Cervical Foraminotomy for Radiculopathy After Cervical Artificial Disc Replacement: Technique Description and Case Report
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Keywords

  • disc replacement
  • cervical spine
  • FDA IDE trial
  • PEEK-on-ceramic device
  • clinical outcome

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