Bioabsorbable bone fixation plates for X-ray imaging diagnosis by a radiopaque layer of barium sulfate and poly(lactic-co-glycolic acid).

Bone fixation systems made of biodegradable polymers are radiolucent, making post-operative diagnosis with X-ray imaging a challenge. In this study, to allow X-ray visibility, we separately prepared a radiopaque layer and attached it to a bioabsorbable bone plate approved for clinical use (Inion, Finland). We employed barium sulfate as a radiopaque material due to the high X-ray attenuation coefficient of barium (2.196 cm(2) /g). The radiopaque layer was composed of a fine powder of barium sulfate bound to a biodegradable material, poly(lactic-co-glycolic acid) (PLGA), to allow layer degradation similar to the original Inion bone plate. In this study, we varied the mass ratio of barium sulfate and PLGA in the layer between 3:1 w/w and 10:1 w/w to modulate the degree and longevity of X-ray visibility. All radiopaque plates herein were visible via X-ray, both in vitro and in vivo, for up to 40 days. For all layer types, the radio-opacity decreased with time due to the swelling and degradation of PLGA, and the change in the layer shape was more apparent for layers with a higher PLGA content. The radiopaque plates released, at most, 0.5 mg of barium sulfate every 2 days in a simulated in vitro environment, which did not appear to affect the cytotoxicity. The radiopaque plates also exhibited good biocompatibility, similar to that of the Inion plate. Therefore, we concluded that the barium sulfate-based, biodegradable plate prepared in this work has the potential to be used as a fixation device with both X-ray visibility and biocompatibility.

Biodegradable internal fixation plates enabled with X-ray visibility by a radiopaque layer of ß-tricalcium phosphate and poly (lactic-co-glycolic acid).

Biodegradable polymer plates can be clinically used as an alternative to metal plates (e.g., titanium) for internal fixation, which, however, are not visible with X-ray imaging, often used for post-operative diagnostics. In this study, therefore, we prepared a biodegradable plate enabled with X-ray visibility by attaching a radiopaque layer on a biodegradable fixation plate in clinical use (Inion, Finland). A radiopaque layer was made of a fine powder of a radiopaque agent, ß-tricalcium phosphate (TCP) and a biodegradable binder material, poly (lactic-co-glycolic acid) (PLGA), which were physically mixed without change in their chemical structure. The radiopacity increased as we increased the layer thicknesses from 0.5 mm to 1.3 mm. Regardless of layer thickness, however, the radiopacity decreased with time both in vitro and in vivo due to decreasing density of TCP in the layer by swelling and degradation of a binder material, PLGA. The in vivo study with rabbits revealed that a discernible image of the radiopaque plate could be obtained by X-ray for up to 21 days, also showing the overall biocompatibility 6 months after implantation. Therefore, we conclude that the radiopaque plate prepared in this work is a promising fixation device enabled with both X-ray visibility and biodegradability.