Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up.
FDA IDE trial
PEEK-on-ceramic device
cervical spine
clinical outcome
disc replacement
Journal
International journal of spine surgery
ISSN: 2211-4599
Titre abrégé: Int J Spine Surg
Pays: Netherlands
ID NLM: 101579005
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
pubmed:
21
7
2021
medline:
21
7
2021
entrez:
20
7
2021
Statut:
ppublish
Résumé
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. 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 The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; 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. 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. 2.
Sections du résumé
BACKGROUND
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
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
RESULTS
RESULTS
The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%;
CONCLUSIONS
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
CONCLUSIONS
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
METHODS
2.
Identifiants
pubmed: 34281951
pii: 8084
doi: 10.14444/8084
pmc: PMC8375704
doi:
Types de publication
Journal Article
Langues
eng
Pagination
633-644Informations de copyright
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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