Background Pedicle screw placement is a commonly performed procedure. Robot-guided screw placement is a recent technological advance that has shown accuracy and reliability with first-generation platforms. Objective To report our initial experience with the safety, feasibility, and learning curve associated with pedicle screw placement utilizing next-generation robotic guidance. Methods A retrospective chart review was conducted to obtain data for 20 patients who underwent lumbar pedicle screw placement under robotic guidance after undergoing interbody fusion for lumbar spinal stabilization for degenerative disc disease with or without spondylolisthesis. The newest generation Mazor X (Mazor Robotics Ltd, Caesarea, Israel) was used. Accuracy of screw placement was determined to be grade I to IV. Grade I was in the pedicle (no breach/deviation), grade II was breach < 2 mm, grade III was breach 2 to 4 mm, and grade IV was breach >4 mm; breach direction (superior, lateral, inferior, or medial) was also recorded. Results Twenty patients underwent robotically assisted pedicle screw placement of 75 screws at 24 levels. Seventy-four screw placements (98.7%) were grade I; 1 (1.3%) was grade II (medial). No complications occurred. Mean time for screw insertion was 3.6 min. Mean fluoroscopy time was 13.1 s and mean radiation dose was 29.9 mGy. CONCLUSION We found that next-generation robotic spine surgery was safe and feasible with reliable and precise accuracy and a minimal learning curve. As this technology improves, further novel applications are expected to develop. Further research is needed to determine long-term efficacy.
IntroductionAfter infection, herpes simplex virus-1 (HSV1) becomes latent in the trigeminal ganglion and can enter the brain via retrograde axonal transport. Recurrent reactivation of HSV1 may lead to neurodegeneration and Alzheimer’s disease (AD) pathology. HSV1 (oral herpes) and HSV2 (genital herpes) can trigger amyloid beta-protein (Aβ) aggregation and HSV1 DNA is common in amyloid plaques. Anti-HSV drugs reduce Aβ and phosphorylated tau accumulation in cell-culture models. Cognitive impairment is greater in patients with HSV seropositive, and antiviral drugs show robust efficacy against peripheral HSV infection. Recent studies of electronic health records databases demonstrate that HSV infections increase dementia risk, and that antiviral medication treatment reduces this risk. The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD.Methods and analysisIn patients with mild AD who test positive for HSV1 or HSV2 serum antibodies, valacyclovir, repurposed as an anti-AD drug, will be compared with placebo (lactose pills) in 130 patients (65 valacyclovir and 65 placebo) in a randomised, double-blind, 78-week phase II proof-of-concept trial. Patients on valacyclovir, dose-titrated from 2 g to a targeted oral dose of 4 g daily, compared with placebo, are hypothesised to show smaller cognitive and functional decline, and, using18F-Florbetapir positron emission tomography (PET) and18F-MK-6240 PET imaging, to show less amyloid and tau accumulation, respectively. In the lumbar puncture subsample, cerebrospinal fluid acyclovir will be assayed to assess central nervous system valacyclovir penetration.Ethics and disseminationThe trial is being overseen by the New York State Psychiatric Institute Institutional Review Board (protocol 7537), the National Institute on Ageing, and the Data Safety Monitoring Board. Written informed consent is obtained for all subjects. Results will be disseminated via publication, clinicaltrials.gov, media and conferences.Trial registration numberClinicalTrials.gov identifier (NCT03282916) Pre-results.
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