Two-level Overall Trial Success: The Composite Endpoint

Success Criteria

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 two-level trial included 330 randomized subjects, 225 Mobi-C and 105 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 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

Two-level Overall Trial Success 

Mobi-C
Fusion
 

* p < 0.0001
† Fisher Exact test used to compare treatments to establish superiority.

Results

Mobi-C established superiority to fusion at two contiguous levels (p<0.0001). 

2 level Clinical Results

As shown in the chart, Mobi-C showed success earlier and with higher rates than fusion at all timepoints.

Two-level Overall Trial Success Over Time

Mobi-C
Fusion
 

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.

One-level Overall Trial Success: The Composite Endpoint

Success Criteria

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
Fusion
 

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 (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

Mobi-C
Fusion
 

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.