Brendan T Keenan Author

Research Article Open Access

One-Year NDI and VAS Outcomes from the Single-Level PEEK-on-Ceramic SimplifyTM Disc FDA IDE Trial

Author(s):

Fred H Geisler, David G Maislin, Brendan T Keenan and Greg Maislin

This study was performed to evaluate the early clinical results at one year for the Simplify™ Cervical Artificial Disc. We compared outcomes for 150 Simplify Disc subjects at one-year followup in a prospective, multicenter, FDA IDE clinical trial with 119 propensity score matched historical control subjects who received conventional anterior cervical discectomy and fusion (ACDF) for single-level cervical degenerative disc disease. The outcome measures included the change from preoperative baseline to one-year in Neck Disability Index (NDI) and visual analog scales (VAS) for neck and arm pain, with scores for the few missing oneyear follow-up implicitly imputed using mixed models for repeated measures (MMRM). The MMRM was used to estimate within group a... view more»

DOI: 10.4172/2325-9701.1000320

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