Special Biodegradable Fixation Device for Anterior Cruciate Ligament Reconstruction-Safety and Efficacy in a Beagle Model.

Abstract

This study aimed to evaluate the safety and efficacy of the special WE43 magnesium alloy stretch plates (SPs) used as fixation device for anterior cruciate ligament (ACL) reconstruction in a beagle model. Eleven beagle dogs underwent ACL reconstruction using WE43 SPs to fix the ligament grafts with the femoral ends, whereas titanium interferences were employed in the tibia ends. Load-to-failure tests were conducted to evaluate the mechanical properties. A comprehensive set of histological observations was performed to observe the local tissue response and assess the status of the attachment between the bone tissue and ligament grafts. Microcomputed tomography and scanning electron microscopy in conjunction with energy spectrum analysis were conducted to evaluate the degradation rate in vivo and investigate the morphology of the cross-section of the SPs and the element distribution in vivo. Immersion tests were employed to investigate the corrosion properties in vitro. The special WE43 SPs showed not only good mechanical strength but also a suitable degradation rate in vivo. The results indicated the special WE43 SP could be considered as a novel fixation device for ACL reconstruction.