Mobi-C® Cervical Disc
Orthopedic Partners proudly offers State Of The Art Treatment For Cervical Disc Disease with Mobi-C artificial Disc Technology.
Dr. Halperin & Mobi-C
After a rigorous Food and Drug Administration (FDA) clinical trial, Mobi-C received approval in 2013, making it the first cervical disc approved for use at both one and two-levels. In 2018, the FDA approved the 7-year clinical results, confirming Mobi-C at two-levels demonstrated SUPERIORITY over fusion based on overall study success. Results at 7 years found Mobi-C at one-level to be statistically non-inferior or equivalent to fusion in terms of overall study success. Those patients who received two-level cervical disc replacement during the trial returned to work on average approximately three weeks earlier as compared to the fusion patients. At 7 years, the Mobi-C patients also had lower rates of subsequent surgeries and reduced rates of ongoing degeneration at spinal segments adjacent to the surgery compared to fusion.
Artificial Disc Technology
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 75,000 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 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.
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 60.8% for Mobi-C and 34.6% for fusion, which represents statistical superiority (p=0.0002).
- The rate of subsequent surgeries at the operated level for Mobi-C was 5.6% versus 17.1% for fusion.
- The percentage of subjects who demonstrated clinically relevant adjacent segment degeneration (determined by x-ray) was:
- 5.3% of Mobi-C patients compared to 40.0% of ACDF patients at the inferior adjacent level
- 11.0% of Mobi-C patients compared to 26.7% of ACDF patients at the superior adjacent level
- Mean return to work time was 20.9 days sooner 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.