Predicting the Failure Risk of Internal Fixation Devices in Chinese Patients Undergoing Spinal Internal Fixation Surgery: Development and Assessment of a New Predictive Nomogram.

The current study is aimed at developing and validating a nomogram of the risk of failure of internal fixation devices in Chinese patients undergoing spinal internal fixation. We collected data from a total of 1139 patients admitted for spinal internal fixation surgery at the First Affiliated Hospital of Guangxi Medical University from May 2012 to February 2019. Of these, 1050 patients were included in the spinal internal fixation group and 89 patients in the spinal internal fixation device failure group. Patients were divided into training and validation tests. The risk assessment of the failure of the spinal internal fixation device used 14 characteristics. In the training test, the feature selection of the failure model of the spinal internal fixation device was optimized using the least absolute shrinkage and selection operator (LASSO) regression model. Based on the characteristics selected in the LASSO regression model, multivariate logistic regression analysis was used for constructing the model. Identification, calibration, and clinical usefulness of predictive models were assessed using C-index, calibration curve, and decision curve analysis. A validation test was used to validate the constructed model. In the training test, the risk prediction nomogram included gender, age, presence or absence of scoliosis, and unilateral or bilateral fixation. The model demonstrated moderate predictive power with a C-index of 0.722 (95% confidence interval: 0.644-0.800) and the area under the curve (AUC) of 0.722. Decision curve analysis depicted that the failure risk nomogram was clinically useful when the probability threshold for internal fixation device failure was 3%. The C-index of the validation test was 0.761. This novel nomogram of failure risk for spinal instrumentation includes gender, age, presence or absence of scoliosis, and unilateral or bilateral fixation. It can be used for evaluating the risk of instrumentation failure in patients undergoing spinal instrumentation surgery.