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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 August 2021, 15 (4) 633-644; 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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  • Figure 1
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    Figure 1

    The PEEK-on-ceramic device investigated in the current study. The PEEK endplates are coated with plasma-spray titanium and the core is ceramic (image courtesy of Simplify Medical, with permission).

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    Figure 2

    The derivation of the 2 treatment groups.

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    Figure 3

    The mean Neck Disability Index (NDI) scores were similar in the 2 groups prior to surgery and were significantly improved throughout follow-up in both groups (P < .001), with the total disc replacement (TDR) group having significantly lower scores at all follow-up points (*P < .025; propensity score [PS] adjusted). Subjects were censored at index-level secondary surgical interventions and intraoperative deviations.

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    Figure 4

    The mean visual analog scale (VAS) neck and arm pain scores were similar in the 2 groups prior to surgery and were significantly improved at all follow-up points (P < .001). The mean scores in the total disc replacement (TDR) group were statistically significantly less than ACDF values at the 3-, 6-, and 24-month follow-ups (P < .05, propensity score [PS] adjusted). Subjects were censored at index level secondary surgical interventions and intraoperative deviations.

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    Figure 5

    Flexion and extension radiographs from the 24-month follow-up shows the motion of the implant at the C6-7 level.

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    Figure 6

    There was little change in the severity of facet joint degeneration at the total disc replacement (TDR) at the 24-month follow-up compared with the preoperative MRIs (subjects censored at index level secondary surgical interventions and intraoperative deviations).

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    Figure 7

    Preoperative and 24-month postoperative MRI of the C6-7 level after total disc replacement (TDR) implantation showing no changes in the facet joints.

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International Journal of Spine Surgery
Vol. 15, Issue 4
1 Aug 2021
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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 Aug 2021, 15 (4) 633-644; 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 Aug 2021, 15 (4) 633-644; DOI: 10.14444/8084
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More in this TOC Section

  • 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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