Isolation and characterisation of wear debris surrounding failed total ankle replacements

Aseptic loosening and osteolysis continue to be a short- to mid-term problem for total ankle replacement (TAR) devices. The production of wear particles may contribute to poor performance, but their characteristics are not well understood. This study aimed to determine the chemical composition, size and morphology of wear particles surrounding failed TARs. A recently developed wear particle isolation method capable of isolating both high- and low-density materials was applied to 20 retrieved periprosthetic tissue samples from 15 failed TARs of three different brands. Isolated particles were imaged using ultra-high-resolution imaging and characterised manually to determine their chemical composition, size, and morphology. Six different materials were identified, which included: UHMWPE, calcium phosphate (CaP), cobalt chromium alloy (CoCr), commercially pure titanium, titanium alloy and stainless steel. Eighteen of the 20 samples contained three or more different wear particle material types. In addition to sub-micron UHMWPE particles, which were present in all samples, elongated micron-sized shards of CaP and flakes of CoCr were commonly isolated from tissues surrounding AES TARs. The mixed particles identified in this study demonstrate the existence of a complex periprosthetic environment surrounding TAR devices. The presence of such particles suggests that early failure of devices may be due in part to the multifaceted biological cascade that ensues after particle release. This study could be used to support the validation of clinically-relevant wear simulator testing, pre-clinical assessment of fixation wear and biological response studies to improve the performance of next generation ankle replacement devices.

Automated summary

Aseptic loosening and osteolysis remain challenges for total ankle replacement devices. The chemical composition, size, and morphology of wear particles surrounding failed TARs were investigated in this study. Six different materials, including UHMWPE, calcium phosphate, cobalt chromium alloy, commercially pure titanium, titanium alloy, and stainless steel, were identified in the wear particles. The presence of mixed particles suggests a complex periprosthetic environment surrounding TAR devices, which may contribute to early device failure. This study provides valuable information for testing, assessment, and improvement of next-generation ankle replacement devices.