The Mobi-C IDE trial was multi-centered, prospective, and controlled. Mobi-C, the investigational treatment, was compared to the control, anterior cervical discectomy and fusion (ACDF). The one-level trial included 245 randomized subjects, 164 Mobi-C and 81 fusion subjects (a 2 to 1 ratio, respectively).
Trial success was based on a composite endpoint. A subject was considered a success at 60 months if all of the following criteria were met:
- Sufficient Neck Disability Index (NDI) improvement (≥ 15 points in subjects with baseline ≥30 points, or ≥ 50% improvement in subjects with baseline <30 points)
- No subsequent surgery at the treated level
- No major complications defined as:
- No radiographic failure
- No neurologic deterioration
- No adverse event determined to be a major complication
One-level Overall Trial Success
Mobi-C established non-inferiority to fusion at one-level. Of all composite endpoint criteria, Mobi-C and fusion subjects were most likely to fail the NDI success standard (20.4% and 19.3% of randomized subjects, respectively).
As shown in the chart, Mobi-C showed higher success rates than fusion at all timepoints.
One-level Overall Trial Success Over Time
Note: All trial subjects were followed and monitored per FDA requirements until seven years post-operative.
The Mobi-C received CE mark approval in 2004 and is currently distributed in 25 countries in Europe, Asia, and the Americas. Through 2015, over 40,000 Mobi-C devices have been implanted worldwide.