Mobi-C^® Clinical Trial Results

Success Criteria

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

Results

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.