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Research Mission:  An assessment of P-15 Bone Putty in Anterior Cervical Fusion with instrumentation. 

Degenerative disc disease (DDD) of the cervical spine can result in significant neck/interscapular pain as well as numbness and tingling in the arms and sometimes when severe, can cause gait and dexterity difficulties.  Normally, cervical DDD is treated conservatively; however, when this treatment option fails, then surgery is an option.  The standard approach as described by Cloward, Smith, and Robinson since the 1950's has been an anterior decompression, restoration of cervical alignment and height, and stabilization.  The decompression is achieved by complete disc/osteophyte removal.  Restoration is achieved by either autograft or allograft.  Stabilization is achieved by anterior plating.  Most surgeons, after complete removal of the disc use an allograft to restore the cervial alignment because autograft is associated with a 20-30% complication rate in the form of either a hemtoma, infection, persistent pain, fracture, and/or nerve palsy.  In this modern era of bioengineering, many substances have been developed to help induce bone formation; however, not one has been FDA approved for the cervical spine.
The surgeons at the Center for Spinal Disorders are excited to be the main Principal Investigators for an Investigational Device (IDE) FDA clinical study in the United States.  P-15 is a synthetic bone substitute that has proven to significantly improve bone repair in dental applications.  The aim of this FDA clinical trial is a non-inferiority study of P-15 Bone Putty in effectiveness and safety to local autologous bone when applied in instrumented cervical discectomy and fusion with the use of a structural ring allograft.  Anterior cervical discectomy and fusion is one of the most common operations for Dr. Janssen and Dr. McPherson who see great promise with P-15.