The Mobi-C IDE trial was a multi-centered, prospective, and randomized controlled trial. 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 84 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 (23.5% and 22.2% of randomized subjects, respectively).
As shown in the chart, Mobi-C showed nominally higher success rates than fusion at all timepoints.
One-level Overall Trial Success Over Time