Cervical Disc Replacement

Cervical disc replacement surgery is much like surgery for lumbar disc replacement, but involves the discs located in the neck. The potential benefits of a cervical disc replacement compared to a fusion are similar to the lumbar procedure – artificial cervical discs provide  faster recovery times than fusion and increased movement after the procedure.

Kineflex™ (completed FDA study)

This study compares the Kineflex-C™  artificial cervical disc to one-level anterior cervical fusion with plating.

Kenneth A. Pettine, M.D., was originally the principal investigator for this FDA investigational device experiment (IDE) study but was replaced by E. Jeffrey Donner, M.D., in January 2007 due to our site’s initiation into an additional artificial cervical disc study.

This study involves the clinical comparison of performing a one-level anterior cervical fusion allograft with plating versus an experimental artificial cervical disc replacement (Kineflex-C™) at C3-C7. This disc is an experimental three-piece metal-on-metal design. It has a unique posterior center of rotation and keel fixation into the cervical spine. The patients were randomized prospectively into receiving either one of these treatments for a herniated disc in the cervical spine causing arm pain with related neck pain.

The first implanted artificial cervical disc in the United States was performed in July 2005. Dr. Pettine implanted our site’s first disc on September 22, 2005. There were 19 patients enrolled at our site. We currently have more than 3-year follow-up data on all those patients. Overall, 325 patients were enrolled into this study at 21 different U.S. sites.

The results of this study are being collated amongst all of the sites in the United States. When minimum two-year follow-up has been received from the first patient, this data will then be submitted to the FDA. It is anticipated the Kineflex-C™ artificial cervical disc will receive FDA approval for use in the cervical spine for the stated treatment. This study is currently closed with continued patient follow-up.

NeoDisc™ (completed FDA study)

This study is a clinical comparison of the NeoDisc™ cervical disc replacement device versus anterior cervical fusion and plating for treatment of cervical disc herniation.

Kenneth A. Pettine, M.D., is the principal investigator of this FDA IDE study comparing the clinical efficacy of an experimental artificial cervical disc replacement, the NeoDisc™, versus anterior cervical fusion with allograft and plating.

Cervical disc replacement has been proposed as a motion preserving way to stabilize the degenerated cervical spine. The NeoDisc™ device is a cervical disc replacement device that consists of a compliant elastomeric core encased in an embroidered polyester jacket. The embroidered jacket features anterior fixation phalanges that interdigitate for immediate positional stability and, along with the entire jacket, induces soft tissue in-growth for long-term stability. The FDA IDE study consisted of prospectively randomizing patients into receiving either the NeoDisc™ artificial cervical disc versus fusion.

The first case performed in the United States was on September 15, 2006 and the first case performed at The Spine Institute was on October 17, 2006. Of the 488 patients enrolled at 23 sites across the United States, the Spine Institute enrolled more patients into this FDA IDE study than any other site. We are currently gathering two-year minimum follow-up on all of the patients. Kenneth A. Pettine, M.D., also performed the first two-level, three-level and four-level NeoDisc™ in the entire world on October 8, 2007, October 30, 2007 and July 29, 2008 respectively. These procedures were performed through an FDA compassionate exemption. The study is currently closed with patient follow-up.

Discover Disc™ (currently in FDA study)

This study is a clinical comparison of the Discover Disc cervical disc replacement device versus anterior cervical fusion.

The Discover is a chrome cobalt disc that has an ultra-high molecular weight density polyethylene insert. It has teeth allowing for immediate fixation to the bone with long-term bony in-growth.

Kenneth A. Pettine M.D. is the principal investigator of this FDA IDE study comparing the clinical efficacy of an experimental artificial cervical disc replacement, the Discover, with anterior cervical fusion.

This study is currently closed.

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