Clinical comparison of 2 implantation systems for single-level cervical disk replacement.

The safety and effectiveness of 2 implantation systems for single-segment cervical disk replacement-the Bryan Cervical Disc System (Medtronic Inc, Minneapolis, Minnesota) and the ACCEL system (Medtronic Inc)-have not been clinically compared. A prospective, nonrandomized controlled study in consecutive patients with a minimum 2-year follow-up was performed. Fifty patients with single-level cervical disk degeneration who responded poorly to conservative treatment and underwent Bryan Cervical Disc replacement were involved. Fifty patients were included (24 in group A [Bryan Cervical Disc System] and 26 in group B [ACCEL system]).The patients' visual analog scale scores, Neck Disability Index (NDI) scores, Short Form 36 (SF-36) scores, Odom scores, operative time, blood loss, and complications were compared. Patients' baseline statuses were similar (P>.05). Visual analog scale for neck and arm pain, NDI, and SF-36 were significantly improved postoperatively (P<.05) in both groups, and no clinical differences were found between the groups (P>.05). All Odom scores were better than good. Mean operative time and average blood loss in group A (173±42.5 minutes and 250±159.8 mL, respectively), were both significantly higher than the values in group B (137.5±19.3 minutes and 138.1±86.7 mL, respectively) (P<.05). Complications included intraoperative bleeding, temporary throat discomfort, and slight migration of the prosthesis; there was no significant difference in the total complication rates between the 2 groups (P>.05). The 2 implantation systems displayed equal clinical effectiveness and safety, but the ACCEL system appears to have the advantages of shorter operative time and less blood loss. Copyright 2014, SLACK Incorporated.

RCT Entities:   Population Interventions Outcomes