P104. Enhancement and Maintenance of Lordosis With Anterior Titanium Cages in the Distal Spine of Adult Lumbar Deformity Patients

discogenic pain due to one-level degenerative disc disease unresponsive to nonoperative treatment. The randomization ratio is 2:1. PATIENT SAMPLE: 75 patients (49 artificial discs and 26 controls) randomized in a 2:1 ratio. 43 patients have achieved 1-year follow-up (30 artificial discs and 13 controls). 6 patients have been evaluated at the 2-year mark (4 artificial discs and 2 controls). OUTCOME MEASURES: Oswestry Disability Index (ODI) back pain, visual analog pain score (VAS) METHODS: Prospective data were collected preoperatively and at defined intervals postoperatively. RESULTS: Oswestry Disability Index (ODI) preoperatively was 61 (Flexicore) and 59 (control). At 6-week follow-up Flexicore-36, control-50; at 3 months Flexicore-31, control-30; at 6 months Flexicore-25, control-27; at 12 months Flexicore-19 control-26; at 24 months Flexicore-3 control-4. Visual analog pain score (VAS) preoperatively was 86 (Flexicore) and 83 (control). At 6-week follow-up Flexicore-30, control-45; at 3 months Flexicore-39 control-33; at 6 months Flexicore-32, control-28; at 12 months Flexicore-22, control-40. Range of motion in flexion/extension preoperatively was an average of 8 degrees; the Flexicore group postoperatively was 5 degrees. Lateral bending averaged 4 degrees preoperatively and 3 degrees after Flexicore disc replacement. CONCLUSIONS: These initial results demonstrate the Flexicore artificial disc to compare very favorably with circumferential fusion for the treatment of lumbar degenerative disc disease unresponsive to nonoperative treatment at the 1-year follow-up period. FDA DEVICE/DRUG STATUS: Flexicore artificial disc: Investigational/ not approved. CONFLICT OF INTEREST: Author (RS) Grant/Research Support: Stryker.