Metal ion release from fracture fixation devices: a potential marker of implant failure.

Stainless steel is the alloy most frequently used for fracture fixation devices (FFD). We aimed to verify if the ion release evaluation could be a surrogate marker of performance and could allow an early detection of implant failure in patients with stainless steel FFD. We measured the nickel (Ni) and chromium (Cr) serum content in patients undergoing the retrieval of stainless steel plates (group I) or intramedullary nails (group II), because of consolidation or failure. Forty-five healthy donors were recruited as controls. Furthermore, the diagnostic performance of these values was evaluated: analysis power, sensitivity, specificity, positive and negative predictive values, likelihood ratios, and diagnostic accuracy were calculated. A significant increase of ion values was demonstrated in patients with failed plates, compared with the values recorded in patients with well-fixed plates (p = 0.002 for Cr and p = 0.002 for Ni), and in healthy subjects (p = 0.0002 for Cr and p = 0.003 for Ni). No significant difference was found between stable implants and controls (p = 0.8 for Cr and p = 0.06 for Ni). A high specificity (0.92 for Cr and 1.00 for Ni), positive predictive value (0.87 for Cr and 1.00 for Ni), and positive likelihood ratio (9.10 for Cr) were calculated for ion testing in plates. The substantial metal content elevations in patients with plates and the positive likelihood ratio above 5 for chromium testing suggest that ion dosage may be a useful surrogate marker for the presence of malfunctioning of these devices, perhaps before the onset of clinical and radiographic changes. © 2007 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2008