Correlation of tissue reaction to corrosion in osteosynthetic devices.

This study evaluated the interaction of osteosynthetic plates to adjacent tissue. Eleven patients had 13 plates removed with simultaneous biopsies of the adjacent soft tissue. Four patients had pain localized to the area of the plate and 11 patients had routine removal or removal for fracture nonunion. Each plate was graded on a 0-5 point scale for the amount and severity of corrosion present at the screw-plate interface. The adjacent tissue was fixed in formalin and stained with hematoxylin and eosin. The tissue reaction was graded on a 0-5 point scale based on the inflammatory response. A positive correlation of corrosion and tissue reaction was found that was significant at p less than 0.005 in the asymptomatic group. The other good correlation showed that tissue reaction tends to decrease with time at p less than 0.005. There was no correlation of corrosion with tissue reaction in the symptomatic removal group. All patients with pain adjacent to the plates were relieved by implant removal. The findings suggest that stainless steel is minimally toxic to human tissue in most circumstances and that the toxic products are well tolerated. There was a significant group (4/11) that showed a different pattern of tissue response which did not appear to be toxic response. We do not recommend routine implant removal to prevent metal toxicity; however, there is a group of patients who have pain in the area of the implant that may be caused by an allergic reaction and is relieved by implant removal.