PEEK-on-ZTA ceramic Total Disc Replacement
This is the conclusion of the IDE study published in the International Journal of Spine surgery. The purpose of this study performed by Guyer et al. (TX, USA) was to compare the PEEK-on-Ceramic (ZTA) total disc replacement (TDR) (Simplify Medical/Nuvasive) to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc degeneration.
The study (Level of Evidence II) was a prospective, deliberately non-randomized, historically controlled, and multicentre trial. All radiographic and MRI assessments were performed by an independent specialist image analysis lab.
The following outcomes were investigated:
- Clinical Composite success
- Neck Disability Index success
- Neurological success
- Revision
- Device failure
- Adverse Events
Guyer et al. also investigated the behaviour of the PEEK-on-Ceramic materials on 150 patients used in TDR for their ability to perform MRI with minimal artifacts compared with metallic devices. Patients were evaluated prior to surgery and postoperatively within 2 weeks, 6 weeks, and 3, 6, 12 (radiographic assessment included) and 24 months (MRI).
Results
At the 24-month follow up, success rate was significantly greater in the TDR group (93%) than in the ACDF control group (73.6%).
Outcome Assessment: the TDR group had significantly improved Neck Disability Index score and neurological status than the ACDF control group.
Device failures or complications related to the PEEK-on-ceramic materials were not reported.
The minimal artifacts associated with PEEK and ceramic materials allowed MRI assessment of the spinal canal and exiting nerve roots with little or no distortion at the TDR level, avoiding the additional risks and costs incurred by the usage of CT.
📚 Reference: Guyer RD, Coric D, Nunley PD, et al. Single-level cervical disc replacement using a PEEK-on-ceramic implant: Results of a multicenter FDA IDE trial with 24-month follow up. The Spine Journal. 2021;21(9):S2-S3. doi:10.1016/j.spinee.2021.05.029.