The primary overall objective of this Fast Track proposed study is to commercially manufacture and mechanically validate anatomically and mechanically accurate synthetic analogue lumbar spine models. Though not yet mechanically validated, Pacific Research Laboratories (PRL) already manufactures composite analogue vertebrae. In Phase I, the investigators will work together to transfer current research concepts to create commercially manufactured mechanical analogue soft tissues for the lumbar spine. This technology will allow formation of a commercially available lumbar spine model that will be mechanically evaluated, iteratively redesigned if required, and validated for overall mechanical performance in bending and compression. In Phase II, the investigators will do research on methods to incorporate and validate basic techniques for incorporating nearly turn-key measurement of facet joint load and intervertebral disc pressures into the lumbar analogue spine model. Though research concepts for these measurement techniques have been partially developed and implemented in prototype models, much more research is required to form techniques that are suitable for consistent commercial manufacture. Complete validation of the measurement techniques and model mechanical performance in comparison to fresh frozen human cadaveric spines will be done. The specific objective of Phase II is then to produce a commercially available, validated lumbar spine model instrumented with facet joint load and disc pressure measurement capabilities. The PI and co-investigators envision that these models can be used in a variety of capacities in spine research and products. The models will aid in understanding of the effects of surgical procedures and implants on potential patient outcomes. ? ? ?
