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Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charite artificial disc represents the first level I data comparison of TDR to fusion. Methods In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charite group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. Results The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. Conclusions The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study.

Multilevel anterior cervical discectomy and fusion (ACDF) remains a difficult problem. A recently described surgical technique for multilevel ACDF has eliminated the morbid complications associated with harvesting iliac crest bone graft (ICBG) while maintaining the advantages of using autologous bone graft. A matched-pairs t test was used to compare the estimated costs of 27 ACDFs using titanium surgical mesh, local autologous bone graft, and anterior plate instrumentation with 27 ACDFs using ICBG and plate fixation. The three variables considered were cage cost, operating time (cost), and hospitalization cost. The estimated costs for the two surgical procedures were not significantly different. Thus, the time saved by not harvesting an ICBG was comparable to the cost of the cage. Harvesting ICBG also increased the morbidity rate by 22%.