The researchers examined data from the prospective, randomized U.S. FDA investigational device exemption study conducted at 24 centers in patients with two-level, contiguous, cervical spondylosis. There were 225 patients who underwent surgery with the Mobi-C cervical total disc and 105 patients who underwent ACDF. The researchers found:
1. There was significant improvement in outcome scores related to the baseline scores during all points of the study.
2. The Mobi-C patients reported significantly more improvement in the Neck Disability Index score, SF-12 Physical Component Summary.
3. The disc replacement patients reported overall patient satisfaction rates 60 months after surgery.
4. The reoperation rate was 4 percent for the Mobi-C patients and 16 percent for the ACDF patients.
5. There wasn’t a significant difference in adverse event rates between the two groups.
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