Compositional and surface changes of retrieved stainless-steel hardware and its effects on surrounding soft tissues: A prospective study

ABSTRACT Purpose: To evaluate the surface, compositional, and histological changes in the overlying soft tissues of retrieved stainless-steel mini-plates and screws used for rigid internal fixation in the maxillofacial skeleton. Materials and Method: A prospective study was conducted comprising 60 patients who sustained maxillofacial trauma and underwent ORIF in our unit previously and who required hardware retrieval in the post-operative phase. The retrieved hardware was evaluated for surface and compositional changes with the help of a scanning electron microscope for surface roughness and corrosion changes. Energy-dispersive X-ray study was done to know the composition and metal release from the hardware. The data obtained from these results were compared with a control unused and a sterile stainless-steel mini-plate and screw. The effects of the corrosion changes of this hardware on the adjacent soft tissues were evaluated histologically to assess the cellular changes of the soft tissue cover overlying the stainless-steel mini-plates and screws. Results: A total of 96 stainless-steel mini-plates and 380 stainless-steel screws were retrieved from 60 patients. The control plate was smooth without any surface and corrosion defects, while the retrieved mini-plates irrespective of the reason for removal have shown surface roughness. Fe and Ni ions were found to be significantly reduced in the retrieved mini-plates. The presence of CrC in the retrieved plates indicates corrosion, which was seen only in hardware retrieved from symptomatic patients. The histological study revealed chronic inflammatory cell infiltrate with hyalinized connective tissue in all the samples irrespective of the reason for the removal of the plate. Conclusion: Stainless-steel mini-plates and screws act as a potent foreign body material and initiate a localized inflammatory reaction due to its corrosive products with longer duration of stay. Hence, the authors advocate the overall shift in the use of stainless-steel hardware to titanium hardware for ORIF.