Alvis MR Author

Research Article Open Access

Preliminary Clinical Outcomes From The Polyetheretherketone On Ceramic Simplifyâ„¢ Disc FDA IDE Trial

Author(s):

Maislin G, Maislin DG, Keenan BT and Alvis MR

Background: This study was performed to evaluate the preliminary clinical results for the Simplify™ Cervical Artificial Disc. Methods: We compared outcomes for the first 61 subjects to reach Month 12 follow-up in a prospective, multicenter, FDA IDE clinical trial with 61 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 Month 12 in Neck Disability Index (NDI) and visual analog scales (VAS) for neck and arm pain with missing follow-up determined by last observation carried forward. Results: The null hypothesis that the Simplify 1-disc is inferior to ACDF (non-inferiority margin=8.4) wa... view more»

DOI: 10.4172/2325-9701.1000304

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