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Cervical Disc Clinical Trial for People with Neck and Arm Pain Set to Begin at Hospital for Special Surgery

New York, NY—September 15, 2014

Millions of people suffer from neck and arm pain as a result of cervical disc disease.

Recently the FDA approved the launch of a clinical trial for the M6-C artificial cervical disc, an innovative implant device developed by Spinal Kinetics, which may offer relief to people with cervical disc herniations resulting in neck and or arm pain. Hospital for Special Surgery (HSS), the number one orthopedic hospital in the nation, is the only hospital in New York City and in the Northeast participating in this trial. Eligible patients can enroll in the upcoming weeks for the nation-wide trial which will compare single-level cervical disc replacement to single-level cervical fusion.

"The M6-C artificial disc is an important innovation because it's the first device that could more effectively simulate the function of a natural intervertebral disc as compared to fusions and previous disc replacement designs," said Dr. Andrew A. Sama, an orthopedic spine surgeon, and the lead HSS investigator of the trial. "The potential benefit for patients suffering from arm and neck pain due to cervical disc injury may be promising and that’s why this trial is such an important one."

The M6-C artificial cervical disc is designed to help patients suffering from single level disc herniations of the spine, a common cause of neck and arm pain as well as numbness. The M6-C technology provides an alternative to spinal fusion and is designed to restore a much more natural motion to the spine. The M6-C is an artificial disc that replicates the anatomic structure and biomechanics of a natural disc.  Like a natural disc, M6-C has a nucleus and an annulus that work together to replicate the motion of a healthy disc, resulting in less strain on surrounding joints and discs. The nucleus absorbs shock and allows compression whereas the annulus provides progressive resistance to motion. 

According to Spinal Kinetics, the M6-C has been available in Europe and other international markets for the past 8 years with excellent clinical results in over 23,000 cases. Several of the country’s leading hospitals and medical centers have been selected to participate. At Hospital for Special Surgery, the trial led by Dr. Andrew A. Sama, also includes orthopedic spine surgeons Dr. Todd J. Albert, surgeon-in-chief; Dr. Frank Cammisa, Chief of the Spine Service; and Dr. Federico Girardi. To join the study or for more information, call 212-774-7183.



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