Two-level Key Trial Results

Mobi-C demonstrated superiority in overall trial success compared to fusion at 84 months. The difference between Mobi-C’s success rate of 60.8% and fusion's rate of 34.6% is statistically superior.

Two-level Overall Trial Success

Mobi-C
Fusion
 

* p < 0.0001
** p=0.0002
† Fisher's Exact test used to compare treatments.
Note: Overall success based on IDE-defined primary endpoint.

At 84 months, Mobi-C demonstrated:

  • Nominally fewer subsequent surgeries at the index levels compared to fusion.
  • Lower average rates of adverse events determined to be major complications compared to fusion.
  • Lower average rates of adjacent level degeneration compared to fusion.
  • A higher Neck Disability Index (NDI) success rate compared to fusion.
  • A mean Range of Motion (ROM) in flexion/extension of 9.3° at the superior index level and 7.4° at the inferior index level.
  • A mean return to work time 20.9 days sooner than fusion.

Mobi-C is a safe and effective surgical option at two contiguous levels in the cervical spine from C3-C7 in indicated subjects.

One-level Key Trial Results

Mobi-C demonstrated non-inferiority in overall trial success compared to fusion at 84 months.

One-level Overall Trial Success

Mobi-C
Fusion
 

At 84 months, Mobi-C demonstrated:

  • Nominally fewer subsequent surgeries at the index level compared to fusion.
  • Lower average rates of adverse events determined to be major complications compared to fusion.
  • Lower average rates of adjacent level degeneration compared to fusion.
  • A mean Range of Motion (ROM) in flexion/extension of 10.2° at the index level.
  • A mean return to work time 7.5 days sooner than fusion.

Mobi-C is a safe and effective surgical option at one-level in the cervical spine from C3-C7 in indicated subjects.

Mobi-C 7-Year and 10-Year Clinical Results