PURPOSE: Measurement of serum metal ion levels is used to determine systemic exposure to implant-derived metal debris that may be generated by processes of wear and corrosion. The aim of this study is to investigate predictors of serum metal ion levels in children undergoing instrumented spinal arthrodesis using a titanium alloy, focusing on implant characteristics and instrumentation construct design variables. METHODS: This prospective longitudinal cohort study involved 33 children. Serum samples were obtained preoperatively:and at five defined interval periods over the first:two post-operative years. Samples were analysed using high resolution:inductively coupled plasma mass spectrometry to measure titanium, niobium and aluminium concentrations. Instrumentation characteristics were catalogued and construct surface area (SA) measurements calculated using an implant-specific software algorithm tool. RESULTS: Significantly elevated levels of serum titanium and niobium were observed (p< 0.0001), with >95 % of post-operative levels abnormally elevated. Significant predictors of serum titanium and niobium levels included time since surgery, surgical procedure (posterior or anterior fusion), number of levels fused, number of pedicle screws inserted, total rod length, total metal SA, total exposed metal SA and total metal-on-metal SA. All significant instrumentation variables were highly correlated. CONCLUSIONS: There is a strong relationship between implant SA and both serum titanium and niobium levels. The direct clinical implications of these findings for patients are uncertain, but remain of concern. Surgeons should be aware of the strong correlation between implant surface area of the chosen construct and the subsequent serum metal ion levels.
PURPOSE: Measurement of serum metal ion levels is used to determine systemic exposure to implant-derived metal debris that may be generated by processes of wear and corrosion. The aim of this study is to investigate predictors of serum metal ion levels in children undergoing instrumented spinal arthrodesis using a titanium alloy, focusing on implant characteristics and instrumentation construct design variables. METHODS: This prospective longitudinal cohort study involved 33 children. Serum samples were obtained preoperatively:and at five defined interval periods over the first:two post-operative years. Samples were analysed using high resolution:inductively coupled plasma mass spectrometry to measure titanium, niobium and aluminium concentrations. Instrumentation characteristics were catalogued and construct surface area (SA) measurements calculated using an implant-specific software algorithm tool. RESULTS: Significantly elevated levels of serum titanium and niobium were observed (p< 0.0001), with >95 % of post-operative levels abnormally elevated. Significant predictors of serum titanium and niobium levels included time since surgery, surgical procedure (posterior or anterior fusion), number of levels fused, number of pedicle screws inserted, total rod length, total metalSA, total exposed metalSA and total metal-on-metalSA. All significant instrumentation variables were highly correlated. CONCLUSIONS: There is a strong relationship between implant SA and both serum titanium and niobium levels. The direct clinical implications of these findings for patients are uncertain, but remain of concern. Surgeons should be aware of the strong correlation between implant surface area of the chosen construct and the subsequent serum metal ion levels.
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