Two-level Trial Design

The Mobi-C IDE trial was multi-centered, prospective, and controlled. The trial tested Mobi-C for non-inferiority to the current standard of care, fusion. The trial planned for the testing of superiority in the event that non‑inferiority was established. The primary trial endpoint analysis was based upon 24 month results. The IDE trial consisted of one-level and two-level treatment arms conducted simultaneously under the same FDA-approved protocol. (The below information focuses on the two-level treatment arm.)

  • Investigational treatment: anterior discectomy followed by insertion of Mobi-C at two-levels
  • Control treatment: anterior discectomy followed by insertion of allograft bone at two-levels and an anterior cervical plate (DePuy Spine Slim-Loc® or the Medtronic Atlantis® or Atlantis Vision®)
  • Randomization scheme: 2 to 1 ratio, Mobi-C to fusion respectively
  • 330 randomized subjects:
    • 225 Mobi-C
    • 105 fusion
  • The trial allowed for 1 nonrandomized training case per site and resulted in 9 nonrandomized Mobi-C subjects in the two-level arm
  • 24 investigative sites
  • Postoperative follow-up: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
    • At the 6 week follow-up visit, Range of Motion (ROM) was not tested for fusion subjects. Overall success was not calculated at this time point because of the missing radiograph analysis.

One-level Trial Design

The Mobi-C IDE trial was multi-centered, prospective, and controlled. The trial tested Mobi-C for non-inferiority to the current standard of care, fusion. The primary trial endpoint analysis was based upon 24 month results. The IDE trial consisted of one-level and two-level treatment arms conducted simultaneously under the same FDA-approved protocol. (The below information focuses on the one-level treatment arm.)

  • Investigational treatment: anterior discectomy followed by insertion of Mobi-C at one-level
  • Control treatment: anterior discectomy followed by insertion of allograft bone at one-level and an anterior cervical plate (DePuy Spine Slim-Loc® or the Medtronic Atlantis® or Atlantis Vision®)
  • Randomization scheme: 2 to 1 ratio, Mobi-C to fusion respectively
  • 245 randomized subjects:
    • 164 Mobi-C
    • 81 fusion
  • The trial allowed for 1 nonrandomized training case per site and resulted in 15 nonrandomized Mobi-C subjects in the one-level arm
  • 24 investigative sites
  • Post-operative follow-up: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
    • At the 6 week follow-up visit, Range of Motion (ROM) was not tested for fusion subjects. Overall success was not calculated at this time point because of the missing radiograph analysis.