Spine
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Randomized Controlled Trial Multicenter Study
Prospective, randomized trial of metal-on-metal artificial lumbar disc replacement: initial results for treatment of discogenic pain.
This study presents data on 67 patients from 2 study sites involved in the multicenter, prospective, randomized, controlled investigational device exemption study of FlexiCore artificial disc replacement versus fusion with a 2-year follow-up. ⋯ These initial results from 2 study sites demonstrate that the FlexiCore compares very favorably to circumferential fusion for the treatment of lumbar DDD unresponsive to conservative treatment. These results are not intended to represent the overall study results.