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INTRODUCTION:Low Back Pain (LBP) is a global healthcare issue, and first line therapy for patients with LBP include physical therapy, oral pain relievers, and steroid injections. If unsuccessful, surgical procedures are indicated. Non-surgical second-line treatments for LBP are warranted, and one example is DiscSeal, a colloidal form of viscous gel composed of polymethyl-methacrylate microspheres and aqueous buffered sodium hyaluronate.METHODS:Six participants were enrolled. The study population comprised of males/females between the ages of 18 and 70, diagnosed with chronic LBP of six months or more prior to enrollment determined to be predominantly caused by discogenic disease of the lumbar spine who failed at least six weeks of conservative management. Participants completed visits at 7, 14, 42, 90, and 180 days.RESULTS:The mean age of participants was 38.8 ± 10.0 years. The mean DiscSeal volume administered was 1.62 ± 0.35 mL with a range between 1.1-2.0 mL. The mean procedure time was 10.8 minutes. Mean LBP visual analog scale (VAS) percentage changes from baseline were -27.0% at 90 days and -42.3% at 180 days, with 50.0% of participants maintaining LBP VAS scores <4 at 90- and 180-days post treatment with DiscSeal. Similarly, mean leg pain VAS percentage changes from baseline were -47.0% at 90 days and -36.6% at 180 days. Overall, participants' average improvement, assessed by Patient Rating Overall Health Status, was 55.2% at 90 days and 67.8% at 180 days.CONCLUSION:The results from this first-in-man trial suggest a favorable safety and efficacy profile for the continued study of DiscSeal. Future studies evaluating DiscSeal as a minimally invasive therapy for chronic discogenic LBP are warranted.

INTRODUCTION:Hydrocephalus is a common pediatric neurosurgical pathology and is typically treated with a ventricular shunt. Shunt complications are common in pediatric hydrocephalus, and ∼30% of patients experience shunt failure during the first year after shunt placement.METHODS:We queried the Healthcare Cost and Utilization Project (HCUP) National Readmissions Database (NRD) from 2016 to 2017 using ICD-10 codes and found 33,248 pediatric patients who underwent shunt placement. Elixhauser comorbidity index (ECI) scores, Johns Hopkins Adjusted Clinical Groups (JHACG) frailty-defining criteria, and Major Diagnostic Category (MDC) classifications were obtained. To determine predictors of shunt complication, the database was divided into a training dataset (n=19,948), a validation dataset (n=6,650), and a testing dataset (n=6,650). Multivariable analysis was performed using the training dataset to identify significant independent predictors of shunt complications in the other datasets. Statistically significant variables were used to develop logistic regression models, and post-hoc receiver operating characteristic (ROC) curves were created.RESULTS:Average age of the 33,248 pediatric patients was 6.9±5.7 years. Variables found to be positively correlated with shunt complications included: number of diagnoses during primary admission (OR: 1.05, 95% CI: 1.04-1.07) and neurological MDCs (OR: 3.83, 95% CI: 3.33-4.42). Variables found to be negatively correlated with shunt complications included: ECI (OR: 0.82, 95%CI: 0.77-0.86), Female sex (OR: 0.87, 95%CI: 0.76-0.99), and elective admissions (OR: 0.62, 95%CI: 0.53-0.72). The ROC curve for the regression model utilizing all significant predictors of readmission in multivariate analysis demonstrated an area under the curve (AUC) of 0.733.CONCLUSION:Expeditious and safe treatment of pediatric hydrocephalus is of paramount importance. Our machine learning algorithm established numerous variables predictive of shunt complications in the pediatric population. Our AUC is suggestive of excellent predictive value. These risk factors may be of clinical importance when evaluating pediatric patients with hydrocephalus.