Long-Term Outcomes of Cervical Disc Replacement and Anterior Cervical Discectomy and Fusion: A Review of FDA IDE Trials With Real-World Comparison.

ABSTRACT: Study designRetrospective comparative cohort study.ObjectiveTo validate FDA IDE-sponsored trial findings on cervical disc replacement (CDR) and anterior cervical discectomy and fusion (ACDF) by comparing reoperation outcomes with real-world data.MethodsPatients undergoing one- or two-level ACDF or CDR from 2010-2022 were identified in the PearlDiver (PD) database. FDA IDE trials were retrieved through review of databases. Subsequent surgeries and sample sizes were extracted at 2-, 4-, 5-, 7-, and 10-year intervals. Event rates were calculated as reoperations divided by patients at risk, and survival probabilities as S(t) = 1-event rate. Kaplan-Meier-style survival curves were reconstructed using the Guyot algorithm with a monotonicity constraint. Pooled FDA survival probabilities were weig

SUBMITTER: Issani A 

PROVIDER: S-EPMC12474576 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature