title: 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.
abstract: 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.
authors: The Spine Surgery PSC, Louisville, Ky.
authors: Richard T
authors: RT
authors: Holt
authors: The Spine Surgery PSC, Louisville, Ky.
authors: Mohammed E
authors: ME
authors: Majd
authors: The Louisiana Orthopedic Institute, Baton Rouge, La.
authors: Jorge E
authors: JE
authors: Isaza
authors: The Texas Back Institute, Plano, Tex.
authors: Scott L
authors: SL
authors: Blumenthal
authors: The Spine and Scoliosis Center, St Joseph's Hospital, Towson, Md.
authors: Paul C
authors: PC
authors: McAfee
authors: The Texas Back Institute, Plano, Tex.
authors: Richard D
authors: RD
authors: Guyer
authors: The Texas Back Institute, Plano, Tex.
authors: Stephen H
authors: SH
authors: Hochschuler
authors: The Illinois Neuro-Spine Center at Rush-Copley Medical Center, Aurora.
authors: Fred H
authors: FH
authors: Geisler
authors: Aventura Hospital and Medical Center, Aventura, Fla.
authors: Rolando
authors: R
authors: Garcia
authors: The West Coast Spine Institute, Beverly Hills, Calif.
authors: John J
authors: JJ
authors: Regan
keywords: IDE trial; artificial disc; complications; lumbar fusion; lumbar spine; randomized study; total disc replacement