title: Experimental design of total disk replacement-experience with a prospective randomized study of the SB Charitè.
abstract: METHODS
  Prospective randomized clinical trial.
  
  
  OBJECTIVE
  To determine if a prospective randomized study of patients with symptomatic degenerative disc disease treated with disc arthroplasty could be safely completed.
  
  
  METHODS
  Sixty patients with one-level discogenic pain confirmed by plain radiography, magnetic resonance imaging, and provocative discography for degenerative disc disease were randomized comparing 1/3 BAK anterior interbody fusion and 2/3 anterior SB Charitè artificial disc replacement.
  
  
  RESULTS
  The mean age was 40.3 years (range 21-56 years). Nineteen cases were at L4-L5 and 41 cases were at L5-S1. Nineteen cases had BAK anterior interbody fusion and 41 cases were randomized as SB Charitè disc replacement. The length of surgery was mean 88.4 minutes (range 54-137 minutes) for both groups. The estimated blood loss was mean 289.5 cc (range 50-1800 cc). The length of hospital stay was a mean of 3.03 days (range 2 to 6 days). Oswestry Disability Index for the BAK control group was 45.9 +/- 10.4 before surgery and 23.5 +/- 17.2 at follow-up (P < 0.001). The corresponding ODI scores for the SB Charitè disc were 50.0 +/- 14.3 before surgery and 25.0 +/- 20.1 at a mean of 2 years' follow-up (P < 0.001).
  
  
  CONCLUSIONS
  This is the first study that shows improvement of functional outcome measures in a prospective randomized design treating primarily mechanical back pain and achieving comparable successful results to lumbar spinal stenosis decompression.
authors.affiliation: Spine and Scoliosis Center, St. Joseph's Hospital, Baltimore, Maryland, Towson, MD 21204, USA. mack8132@aol.com
authors.forename: Paul C
authors.initials: PC
authors.lastname: McAfee
authors.forename: Ira L
authors.initials: IL
authors.lastname: Fedder
authors.forename: Samer
authors.initials: S
authors.lastname: Saiedy
authors.forename: Erin M
authors.initials: EM
authors.lastname: Shucosky
authors.forename: Bryan W
authors.initials: BW
authors.lastname: Cunningham
mesh_terms: D000328:Adult; D019643:Arthroplasty, Replacement / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D013123:Spinal Fusion; D013997:Time Factors; D016896:Treatment Outcome