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PEEK-on-ZTA ceramic returns strong five-year results in cervical total disc replacement

Dr. Richard Guyer and team from the Center for Disc Replacement at Texas Back Institute conducted a clinical trial evaluating the five-year follow-up of single-level PEEK-on-ZTA ceramic cervical TDR procedures against a control group of propensity-score-matched anterior cervical discectomy and fusion (ACDF) procedures. The material focus of this study was the Simplify Cervical Artificial Disc from Globus/NuVasive, made with zirconia-toughened-alumina (ZTA) ceramic. 

The Simplify disc offers two ceramic core sizes tailored to patients' anatomy, with heights as small as 4mm. The ZTA ceramic composition provides minimally invasive sizing while retaining strength and smoothness. It produces clear, distortion-free images on X-ray, CT scan, and MRI, allowing doctors to easily assess ROM and to identify complications under fluoroscopy. This study put the material to the test.  

What the team used:  

  • All 267 patients were treated for single-level cervical disc degeneration with radiculopathy and/or myelopathy (150 underwent TDR, 117 ACDF).  
  • Clinical outcomes were judged on Neck Disability Index (NDI) and visual analog scales (VAS) and assessed for pain, reoperations, and satisfaction level.  
  • Composite Clinical Success was rated based on an NDI score improvement of at least 15 points, no device failure, and no index-level surgery for at least five years.  

  • Radiographic measures included segmental ROM, disc space height, and heterotopic ossification (HO).  

     

What they found:  

  • Composite Clinical Success was significantly greater with TDR (91.1%) than ACDF (74.6%; P <0.01).  
  • In the TDR group, the mean NDI score was 63.3 pre-op; by six weeks post-op it had dropped to 23.1, then below 20 for every subsequent follow-up (the ACDF group, by contrast, started at a comparable level but stayed between 25.9 and 21.5 up to five years post-op).
  • Mean neck and arm pain VAS levels improved post-op in both treatment groups but were lower throughout follow-up for the TDR group.  

  • Mean TDR ROM was 7.3° pre-op and 10.1° five years post-op.  

     

What they say:  

PEEK-on-ZTA TDR outcomes after five years were similar or superior to ACDF outcomes, especially in increasing and preserving patient ROM – an important success for a disc designed to keep natural cervical motion intact. The team advocates for the wider use (where appropriate) of TDR as a procedure.  

Please check for regulatory approval in your country.

 

References:  

Richard D Guyer, Hyun Bae, Domagoj Coric, Pierce D Nunley, Michael Musacchio, Rick C Sasso, and Donna D Ohnmeiss. “Five-year Follow-up of a Prospective Food and Drug Administration Investigational Device Exemption Trial Evaluating a PEEK-on-Ceramic Cervical Disk Replacement.” Spine (Philadelphia 1976) 2025 Jan 1;50(1):1-9. doi: 10.1097/BRS.0000000000005123.  

 

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