ITAP: Clinical outcomes and implant design optimisation using numerical modelling

Abstract

Redistribution of the flow of forces through the body, such as that after amputation and/or implantation of a skeletally anchored amputation prostheses, leads to bone remodelling. Periprosthetic bone resorption can destabilise skeletally anchored amputation prostheses. Therefore, implants that minimise bone resorption will achieve a more successful long term bone fixation. Bone remodelling outcome measures rely on implant design using mechanoregulatory bone remodelling theory. Mechanoregulation is implemented by functions that link a local mechanical stimulus to a local change in the structure or properties of bone material. This thesis uses the strain adaptive remodelling theory at the time of implantation with periprosthetic strain energy density as the outcome parameter. Clinical trial data was collected from a patient with a skeletally anchored amputation prostheses; The Intraosseous Transcutaneous Amputation Prosthesis (ITAP). The clinical trial ran from 2008 – 2019, the data was investigated for patterns between implant design and fixation success. This thesis reports trends in fixation success and bone change using a developed fixation success score. There was an ideal implant length to bone length ratio range and a straight, tapered stem with a flared bone collar growth shape were beneficial to fixation success. Conversely, one or more parameters associated with pressfit fixation were detrimental to fixation success. Results between the clinical and numerical data compared favourably; clinically, regions of periprosthetic bone growth were also observed by regions of high strain energy density in the finite element analysis and vice versa at the implant tip and osteotomy face. This thesis provides skeletally anchored amputation prostheses design guidelines that will minimise bone resorption when measured with strain energy density. Moreover, that future skeletally anchored amputation prostheses parameterised design can and should be used as a tool to assess bone fixation outcome in pre-clinical assessments

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