The broad, long-term objective of this proposal is to commercialize optimized acrylic bone cement mixing and injection components which will improve the long-term fixation of orthopaedic implants and reduce cost. Phase I of the project will aim to design and fabricate prototype cement mixing and injecting components for application to a femoral canal, validate their performance, and experimentally determine the resultant strengths of the cement-bone and cement-metal interfaces. The components will be designed to reduce cost by minimizing the number of disposable parts without compromising function. This work relates directly to the effectiveness and cost containment of joint implants, of which over 350,000 procedures were performed in the U.S. in 1993. The hypothesis that will be experimentally tested is that reducing the time from mixing onset to injection of the cement, increasing the injection shear rate, and ensuring radial pressurization of the cement int he bone canal will improve the strength of the cement-bone and cement-prosthesis interfaces. The hypothesis will be considered by comparing prototype designs to the existing current technology. With a team of research, design, manufacturing, and medical professionals, the tasks will be carried out in a concurrent engineering research and development environment.
For the success of cemented total hip replacements, there is a cost for cementing supplies (without cement costs) of approximately $305 per procedure. It is estimated that 100,000 hip replacements were performed in 1993 in patients aged 65 and over. Assuming this number approximately represents the number of cemented hip replacements, there is a yearly domestic market for cementing supplies for hip replacements of around $30 million. Assuming a market share of only 3% domestically, annual revenues of $900,000 could be generated. If rapid-growth international markets and other joint replacements are projected, much greater revenue would be realized.
