SB Charité Disc Replacement Report of 60 Prospective Randomized Cases in a U . S . Center Paul

Sixty patients with one-level discogenic pain confirmed by plain radiography, magnetic resonance imaging, and provocative discography for degenerative disc disease were randomized: one-third BAK anterior interbody fusion and two-thirds anterior SB Charité artificial disc replacement. 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 Charité 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 mL (range 50–1800 mL). The length of hospital stay was a mean of 3.03 days (range 2–6 days). Oswestry Disability Index scores for the SB Charité disc (aggregate study group) were 50.0 ± 14.3 preoperatively and 25.0 ± 20.1 at 1–3 years’ follow-up (P < 0.001). This is the first study that shows improvement of functional outcome measures in a prospective randomized design with disc arthroplasty treating primarily mechanical back pain and achieving comparable successful results to lumbar fusion—interbody fusion cage and BMP or interbody autograft and pedicle screw instrumentation.