Project Description: 

Currently the option available for very severe distal humerus fractures replaces the entire elbow joint rather than just the fractured section. This is compounded by the fact that 1 in every 5 Total Elbow Arthroplasties (TEAs) require revision surgeries due to loosening within the first 5 years post-surgery. Unfortunately, there are only 3,000 TEA surgeries performed every year, so there has been little motivation to innovate. As a result, aseptic loosening remains a major mode of failure that has yet to be solved. The main cause of aseptic loosening is the wear particles that accumulate and elicit an immune response that results in bone loss. Some studies have found a link between cemented implants and osteoclasts that break down the bone in the immune response to current TEAs. Therefore, “Capped” will be a more affordable, cementless option that only replaces part of the distal humerus rather than the whole elbow, while improving longevity. Our device is made completely of a titanium alloy (TI-6Al-4V), and uses screws into the medial and lateral columns for fixation, eliminating the need for PMMA cement and thus reducing the wear particles that cause loosening. Finite Element Analysis (FEA) testing confirms that our design does not permanently deform when subjected to the elbow’s daily mechanical demands and can easily withstand over 91,000 cycles. Therefore, we believe we have developed a viable solution to this problem.