ArticleInternational journal of spine surgery2021
Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up.
Article in International journal of spine surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- The fragility index and reverse fragility index of FDA investigational device exemption trials in spinal fusion surgery: a systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Pooled it
- Equivalent Clinical Outcomes but Divergent Biological Adaptation After Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty: A Longitudinal MRI Cohort Study.Journal of clinical medicine · 2026Article
- Article
- Analysis of 478 Revision Cases for Cervical Disc Arthroplasty Based on Their Biomechanical Design.International journal of spine surgery · 2026Article
- Propensity Scores for Observational Studies: Putting Real World Data and Experience to Good Use in Spine Research!Global spine journal · 2026Review
- Beyond the two-year trial: real-World failure mechanisms of the simplify cervical disc.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026Review
- Advanced preclinical testing of a design-optimized ceramic bearing for a cervical total disc replacement.PloS one · 2026Article
- Rates of Osteolysis for Commercially Available Cervical Disc Arthroplasty Devices in the United States: A Manufacturer and User Facility Device Experience Database Analysis.International journal of spine surgery · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany 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.
methodsThis 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
resultsThe success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%;
conclusionsThe 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.
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