Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc.

Autor:	Holt RT; The Spine Surgery PSC, Louisville, Ky., Majd ME; The Spine Surgery PSC, Louisville, Ky., Isaza JE; The Louisiana Orthopedic Institute, Baton Rouge, La., Blumenthal SL; The Texas Back Institute, Plano, Tex., McAfee PC; The Spine and Scoliosis Center, St Joseph's Hospital, Towson, Md., Guyer RD; The Texas Back Institute, Plano, Tex., Hochschuler SH; The Texas Back Institute, Plano, Tex., Geisler FH; The Illinois Neuro-Spine Center at Rush-Copley Medical Center, Aurora., Garcia R Jr; Aventura Hospital and Medical Center, Aventura, Fla., Regan JJ; The West Coast Spine Institute, Beverly Hills, Calif.
Jazyk:	angličtina
Zdroj:	SAS journal [SAS J] 2007 Feb 01; Vol. 1 (1), pp. 20-7. Date of Electronic Publication: 2007 Feb 01 (Print Publication: 2007).
DOI:	10.1016/SASJ-2006-0004-RR
Abstrakt:	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 Charité 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 Charité 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.
Databáze:	MEDLINE
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