Published Article / Rapid Manufacturing (RM) has emerged over the past few years as a potential technology to successfully produce patient-specific implants for maxilla/facial and cranial reconstructive surgeries. However, in the area of spinal implants, customization has not yet come to the forefront and with growing capabilities in both software and manufacturing technologies, these opportunities need to be investigated and developed wherever possible. The possibility of using Computed Tomography (CT) and Rapid Manufacturing (RM) technologies to design and manufacture a customized, patient-specific intervertebral implant, is investigated. Customized implants could aid in the efforts to reduce the risk of implant subsidence, which is a concern with existing standard implants. This article investigates how accurately the geometry of a customized artificial intervertebral disc (CAID) can represent the inverse geometry of a patient's vertebral endplates. The results indicate that the endplates of a customized disc implant can be manufactured to a calculated average error of 0.01mm within a confidence interval of 0.022mm, with 95% confidence, when using Direct Metal Laser Sintering.

This thesis describes the development of artificial disc technology for the replacement of intervertebral discs in the human lumbar spine. The clinical problem is back pain. There may be a relationship between certain forms of back pain and disc degeneration. The mechanical properties of human intervertebral discs are examined in detail. The genetic basis of disc degeneration is presented. The hypothesis is that such degeneration leads to a loss of normal stiffness in the segments affected leading to abnormal mechanical behaviour which in turn leads to pain. The evidence for this is presented. The development of surgical solutions to relieve back pain, from fusion through first generation mechanical artificial discs to elastomeric designs, is traced. The author‘s personal contributions to this area of knowledge are set out. The appreciation of the requirement for a restoration of physiological stiffness is argued throughout, showing where fusion and first generation discs have not met the clinical aim of pain relief, because they have not restored physiological stiffness. The path to an elastomeric, viscoelastic, polyhydrocarbon, rubber solution in the form of the “Freedom“ disc has filled 17 years of the author‘s academic pursuits. It will be shown that this technology may represent a possible solution to the clinical problem. Failure is part of all new advancement and this too is presented, to show how that has influenced thinking, producing original ideas to overcome these failures. Providing lessons are learned from these failures then our patients in the future will benefit.

Eight out of ten people in the United States will have problems with low back pain at some point in their life. The most significant surgical treatments for low back pain can be distributed into two main groups of solutions: arthrodesis and arthroplasty. Spinal arthrodesis consists of the fusion of a degenerated functional spine unit (FSU) to alleviate pain and prevent mechanical instability. Spinal arthroplasty consists of the implantation of an artificial disc to restore the functionality of the degenerated FSU. The objective of this study is to analyze and compare the alteration of the biomechanics of the lumbar spine treated either by arthrodesis or arthroplasty. A three-dimensional finite element model of a ligamentous lumbar motion segment, constituted of two FSUs, was built and simulated through a static analysis with the finite element software ABAQUS. It was shown that the mobility of the segment treated by arthrodesis was reduced in all rotational degrees of freedom by an average of approximately 44%, relative to the healthy model. Conversely, the mobility of the segment treated by arthroplasty was increased in all rotational degrees of freedom by an average of approximately 52%. The FSU implanted with the artificial disc showed a high risk of instability and further degeneration. The mobility and the stresses in the healthy FSU, adjacent to the restored FSU in the segment treated by arthroplasty, were also increased. In conclusion, the simulation of the arthroplasty model showed more risks of instability and further degeneration, on the treated level as well as on the adjacent levels, than in the arthrodesis model.

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