Design and evaluation of a prosthetic anterior cruciate ligament replacement medical device
Bach, Jason Samuel
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Rupture of the anterior cruciate ligament (ACL) is a relatively common sports-related injury for which the current treatment is reconstruction with an autograft or allograft. Drawbacks associated with each of the current options would make a prosthetic alternative advantageous, however, artificial ligaments are not widely used, having failed due to lack of biocompatibility and mechanical insufficiencies. To develop the next-generation prosthetic ACL, design control principles were applied including specification of comprehensive design inputs, risk analysis, and verification testing. A design was proposed utilizing polyvinyl alcohol and ultrahigh molecular weight polyethylene, selected for good biocompatibility and mechanical strength and stiffness suitable for ACL replacement. A biomimetic fibrous rope pattern was designed for the intra-articular ligament section of the prosthetic that produced a close match the static tensile behavior of the native ACL and which also demonstrated good resistance to fatigue and creep. A calcium phosphate coating was recommended for the sections of the device lying within the bone tunnel to increase the rate of osseointegration. The proposed design was then evaluated in a computational simulation to assess functional restoration and the effects of installation parameters such as tension and tunnel orientation on knee kinematics. The encouraging results of preclinical verification testing support further in vivo evaluation of the proposed design.
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