SUPERIOR TO FUSION
for two-level disc replacement
at FIVE YEARS
Mobi-C® Cervical Disc
The FIRST and ONLY Cervical Disc FDA Approved for Both One & Two Level Indications
The Mobi-C Cervical Disc is one of the most widely used cervical discs in the world. First implanted in France in November 2004, Mobi-C has been implanted in more than 40,000 spinal levels in 25 countries.
A total of 599 patients were involved in the Mobi-C U.S. clinical trial, which represents the largest concurrent clinical trial ever conducted for cervical disc replacement. Mobi-C received FDA approval in August of 2013, making it the first cervical disc with both one and two-level indications.
Mobi-C – How it Works
Mobi-C contains patented mobile bearing technology that allows the polyethylene core to slide and rotate inside the disc for self-adjustment to the cervical spine movements. This means that Mobi-C can react to the normal motion in the cervical spine.
Mobi-C provides bone sparing fixation without chisel cuts into the small vertebral bodies of the cervical spine, making it bone sparing.
Mobi-C – Clinical Trial Results at 5-Years
In the one-level study, Mobi-C demonstrated non-inferiority to anterior cervical discectomy and fusion (ACDF) as reflected in the primary composite endpoint. In the two-level study Mobi-C demonstrated SUPERIORITY to ACDF in the primary composite endpoint. Key results from the two-level study include:
- Overall trial success was 62.8% for Mobi-C and 34.1% for fusion, which represents statistical superiority (p< 0.0001).
- The rate of subsequent surgeries at the operated level for Mobi-C was 3.8% versus 16.2% for fusion.
- The percentage of subjects who demonstrated adjacent segment degeneration (determined by x-ray) was:
- 77.5% of Mobi-C patients compared to 44.9% of ACDF patients at the inferior adjacent level
- 67.4% of Mobi-C patients compared to 29.2% of ACDF patients at the superior adjacent level
- Mean return to work time was 20.9 days shorter for Mobi-C patients compared to fusion patients.
As with any surgery, complications may occur as a result of treatment. Potential complications following treatment with the Mobi-C include:
- Pain in the neck, arm, back, shoulder, or head.
- The feeling of pins and needles in the arms.
- Difficulty swallowing.
Please visit www.cervicaldisc.com/aboutyourneck for a complete list of potential risks and benefits of Mobi-C surgery. Visit www.cervicaldisc.com/clinical-results for indications and detailed clinical results.