Our team at Texas Back Institute worked as clinical investigators on ProDisc-C, Mobi-C Single Level, and Mobi-C Two Level. We have additionally worked as investigators on several other cervical discs that are not yet FDA approved. These include Simplify Disc Single Level, Simplify Disc Two Level, M-6 Single Level, Discover Disc, and Kineflex.

Mobi-C® Cervical DiscMobi-C® Cervical Disc

  • Only FDA Approved Cervical Disc for One & Two Levels
  • Superior to fusion for two-level disc replacement

The Mobi-C cervical disc is one of the most widely used cervical discs in the world. First implanted in Orleans, France in November 2004, Mobi-C has been implanted in more than 17,000 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.

How the Mobi-C Works

Mobi-C contains patented Mobile Core 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 safe for implantation at two levels.

Mobi-C Clinical Trial Results

In the one-level study, Mobi-C demonstrated non-inferiority to 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 69.7% for Mobi-C and 37.4% for fusion, which represents statistical superiority(p< 0.0001).
  • The rate of secondary surgeries at the operated level for Mobi-C was 3.1% versus 11.4% for fusion.
  • The percentage of subjects who demonstrated adjacent segment degeneration (determined by x-ray) was:
    • 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior adjacent level
    • 13.1% of Mobi-C patients compared to 33.3% 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.
  • 78.2% of Mobi-C patients showed improvement in Neck Disability Index (NDI) based on the FDA success criteria versus 61.8% of fusion patients.

ProDisc-L

ProDisc is a Total Disc Replacement (TDR) technology platform that offers a surgical alternative to spinal fusion. Qualified patients generally suffer from a single level degenerated disc in the upper (cervical) or lower (lumbar) spine. ProDisc implants are intended to relieve pain while allowing the potential for motion at the diseased spinal segment.Synthes Spine is currently the only company in the United States to offer Total Disc Replacement devices for both the upper and lower spine.

ProDisc L: Total disc replacement for the lower (lumbar) spine (L3-S1)

The ProDisc-L Total Disc Replacement device is intended to treat a single degenerated (diseased) disc in the lower spine (L3-S1). The ProDisc-L implant was designed in collaboration with practicing spine surgeons and has been thoroughly tested in both laboratory and clinical settings.

Motion

The ProDisc-L implant allows the potential for motion through its ball and socket design.

  • A plastic inlay affixed to a bottom metal endplate forms the ball.
  • A polished concave metal surface in the top endplate forms the socket.
  • The socket can move over the surface of the ball to allow for controlled and predictable motion.

ProDisc L

Fixation

The ProDisc-L implant is secured to the bones (vertebrae) in the spine with a patented central keel on the top and bottom endplates. A coating has also been applied to all the implant surfaces that contact bone to allow for the bone to grow onto the implant.

ProDisc

Clinical History

The ProDisc I implant, the predecessor of the ProDisc-L implant, was first implanted in 1990. The ProDisc-L implant that is used today was introduced outside the United States in 1999. It was approved by the Food and Drug Administration (FDA) for use in the United States in August 2006.

A ProDisc-L IDE clinical study evaluated the ProDisc-L Total Disc Replacement surgery compared to spinal fusion surgery*. The study demonstrated that ProDisc-L surgery is a safe and effective alternative to fusion surgery* for qualified patients.

More Information

For more information about the ProDisc-L implant and procedure, please refer to the resources provided on the right. This information is not a replacement for professional medical advice. Only your surgeon is qualified to diagnose and treat your condition. *The ProDisc-L surgery was compared to a “Circumferential” fusion surgery, which involves removing the diseased disc and inserting a disc spacer through an incision in the abdomen and attaching metal screws and rods to the back of the spine through incision(s) in the back.

Spinal Surgery – Know your options

Total Disc Replacement surgery with ProDisc is different from traditional spinal fusion surgery. Both surgeries are intended to relieve pain by removing the diseased disc and restoring the height of the affected disc space.

ProDisc-C

The ProDisc-C Total Disc Replacement device is intended to treat a single degenerated (diseased) disc in the upper spine (C3-C7). The ProDisc-C implant was designed in collaboration with practicing spine surgeons and has been thoroughly tested in both laboratory and clinical settings.

Motion

The ProDisc-C implant allows the potential for motion through its ball and socket design.

  • A plastic inlay affixed to a bottom metal endplate forms the ball.
  • A polished concave metal surface in the top endplate forms the socket.
  • The socket can move over the surface of the ball to allow for controlled and predictable motion

ProDisc-C

Fixation

The ProDisc-C implant is secured to the bones (vertebrae) in the spine with a patented central keel on the top and bottom endplates. A coating has also been applied to all the implant surfaces that contact bone to allow for the bone to grow onto the implant.

ProDisc-C close up
Clinical History

The ProDisc-C was developed using the same design principles as the ProDisc-L implant. The first ProDisc-C Total Disc Replacement surgery was performed in Europe in 2002. It was approved by the Food and Drug Administration (FDA) for use in the United States in December 2007.

A ProDisc-C IDE clinical study evaluated the ProDisc-C Total Disc Replacement surgery compared to spinal fusion surgery*. The study demonstrated that ProDisc-C surgery is a safe and effective alternative to fusion surgery* for qualified patients. For more information about the ProDisc-C IDE Study, refer to the ProDisc-C IDE Study Brochure and talk to your doctor.

More Information

This information is not a replacement for professional medical advice. Only your surgeon is qualified to diagnose and treat your condition.

*The ProDisc-C surgery was compared to an ACDF surgery, which involves removing the diseased disc and inserting a spacer into the space through an incision in the front of the nexk. A plate and screws are attached to the bones in the front of the spine to hold the spacer in place and to help promote fusion.

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