COMPLAINT POLYMER LUMBAR ARTIFICIAL DISC PRECLINICAL STUDY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Spine ailments are among the most common and costly illnesses of society today. In the US alone, 30 billion dollars annually are spent on the surgical treatment of low back pain. About 400,000 such surgeries are performed every year. Until recently the 'gold standard' has been to perform a spine fusion. In 2005 FDA cleared for the first time a mechanical total disc replacement (TDR) device to be freely sold in the US (more devices are expected in 2006). Mechanical TDR devices, however, are feared by experts not to have the hoped (and praised) long-term advantages when compared with traditional spinal fusion. Adjacent level degeneration, known to exist as a result of fusion, may still persist as an adverse outcome of disc replacement surgery. In addition, new complications such as poorly guided movements between vertebral bodies causing pain or small wear particles originating from the implant surfaces causing inflammation and ultimately implant loosening may plague the patient. A new artificial disc concept, a so-called "compliant disc", that would potentially not have the above shortcomings, shall be tested in a baboon study for its clinical suitability. The disc implant is comprised of three polycarbonate polyurethane formulations of different hardness for annulus, nucleus and end plate. The end plates have a thin coating of calcium phosphate. A 'pilot' baboon study was performed in May 2006 when a preclinical device was implanted in a single subject. Weekly radiographs documented a stable implant position. Necropsy showed progress in wound healing concomitant with the time frame. Polycarbonate polyurethanes are used in a wide variety of cardiology applications, including LVADs, pacemakers and catheters. Several commercialized orthopedic implant products employ polycarbonate polyurethane.