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Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial
The Spine Journal, 06/15/2012
Singh K et al. – The present study identifies a 2.1% rate of repeat surgery within 2 years of a single–level anterior cervical discectomy and fusion (ACDF) performed during routine clinical practice, which is lower than that reported in the control arm of the Prestige, ProDisc–C, Bryan, Kineflex|C, and Mobi–C FDA trials. Even with longer follow–up including multilevel cases, the reoperation rate compared favorably with the IDE rates. This discrepancy may reflect different thresholds for reoperation in the control arm of a device investigational device exemption (IDE) study compared with routine clinical practice. Additionally, patients enrolled in the single–level–only IDE trial may have received multilevel procedures outside of the study.
