title: Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charité Artificial Disc.
abstract: METHODS
  A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial.
  
  
  OBJECTIVE
  To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study.
  
  
  BACKGROUND
  To our knowledge, an analysis of the effect of surgical volume has not been performed for any spine surgical procedure. Prior reports of the early experience with lumbar total disc replacement consist of retrospective reviews with nonspecific indications.
  
  
  METHODS
  An analysis was performed of the Food and Drug Administration IDE Study of the Charité Artificial Disc (DePuy Spine, Inc., Raynham, MA). Patients enrolled in the control group were omitted from the analysis. Up to 5 nonrandomized cases (representing the early experience) were performed at each site before beginning the randomized arm of the study. There were 3 comparisons performed: nonrandomized cases (71) versus randomized cases (205); randomized cases performed by high-enrolling surgeons versus low-enrolling surgeons; and randomized cases at high-volume institutions versus low-volume institutions.
  
  
  RESULTS
  The high-enrolling groups had a significantly lower mean hospital stay and operating time compared to the low-enrolling groups (P < 0.05). High-enrolling surgeons and institutions showed significantly shorter operating times, length of hospital stay, and complication rates. High-enrolling surgeons had significantly fewer device failures and cases of neurologic deterioration. Mean operating time and hospital stay were significantly lower in the randomized group (P < 0.05) compared to the nonrandomized group. Blood loss and approach-related complications were similar between the 2 groups. Device failure requiring removal was 4.2% in the nonrandomized group and 1.5% in the randomized group.
  
  
  CONCLUSIONS
  Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes.
authors.affiliation: West Coast Spine Institute, Beverly Hills, CA 90212, USA. jjregan@spinesource.com
authors.forename: John J
authors.initials: JJ
authors.lastname: Regan
authors.forename: Paul C
authors.initials: PC
authors.lastname: McAfee
authors.forename: Scott L
authors.initials: SL
authors.lastname: Blumenthal
authors.forename: Richard D
authors.initials: RD
authors.lastname: Guyer
authors.forename: Fred H
authors.initials: FH
authors.lastname: Geisler
authors.forename: Rolando
authors.initials: R
authors.lastname: Garcia
authors.forename: James H
authors.initials: JH
authors.lastname: Maxwell
mesh_terms: D000293:Adolescent; D000328:Adult; D016063:Blood Loss, Surgical / Q000706:statistics & numerical data; D018795:Device Approval; D005260:Female; D006801:Humans; D007403:Intervertebral Disc; D007902:Length of Stay / Q000706:statistics & numerical data; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000706:statistics & numerical data*; D013122:Spinal Diseases / Q000601:surgery*; D016896:Treatment Outcome