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Randomized Controlled Trial Comparative Study
Clinical comparison of 2 implantation systems for single-level cervical disk replacement.
- Rui Shi, Juan Li, Hao Liu, Chen Ding, Tao Hu, Tao Li, and Quan Gong.
- Orthopedics. 2014 Feb 1; 37 (2): e161-8.
AbstractThe 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.
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