Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial.

INTRODUCTION Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment. METHODS AND ANALYSIS This is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient's global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre. ETHICS AND DISSEMINATION Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER NCT02763956. PROTOCOL VERSION 7.1, 18 November 2020

Neurosurgical Resident Training in Germany

Introduction Efficient neurosurgical training is of paramount importance to provide continuing high-quality medical care to patients. In this era of law-enforced working hour restrictions, however, maintaining high-quality training can be a challenge and requires some restructuring. We evaluated the current status of resident training in Germany. Methods An electronic survey was sent to European neurosurgical trainees between June 2014 and March 2015. The responses of German trainees were compared with those of trainees from other European countries. Logistic regression analysis was performed to assess the effect size of the relationship between a trainee being from Germany and the outcome (e.g., satisfaction, working time). Results Of 532 responses, 95 were from German trainees (17.8%). In a multivariate analysis corrected for baseline group differences, German trainees were 29% as likely as non-German trainees to be satisfied with clinical lectures given at their teaching facility (odds ratio [OR]: 0.29; 95% confidence interval [CI]: 0.18-0.49; p  50 hours per week (OR: 2.13; 95% CI, 1.25-3.61; p = 0.005). This working time, however, is less spent in the operating suite (OR: 0.26; 95% CI, 0.11-0.59; p = 0.001) and more doing administrative work (OR: 1.83; 95% CI, 1.13-2.96; p = 0.015). Conclusion Some theoretical and practical aspects of neurosurgical training are superior, but a considerable proportion of relevant aspects are inferior in Germany compared with other European countries. The present analyses provide the opportunity for a critical review of the local conditions in German training facilities

Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial

INTRODUCTION: Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment. METHODS AND ANALYSIS: This is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient's global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER: NCT02763956. PROTOCOL VERSION: 7.1, 18 November 2020

Trends and outcomes for non‑elective neurosurgical procedures in Central Europe during the COVID‑19 pandemic

The world currently faces the novel severe acute respiratory syndrome coronavirus 2 pandemic. Little is known about the efects of a pandemic on non-elective neurosurgical practices, which have continued under modifed conditions to reduce the spread of COVID-19. This knowledge might be critical for the ongoing second coronavirus wave and potential restrictions on health care. We aimed to determine the incidence and 30-day mortality rate of various non-elective neurosurgical procedures during the COVID-19 pandemic.A retrospective, multi-centre observational cohort study among neurosurgical centres within Austria, the Czech Republic, and Switzerland was performed. Incidence of neurosurgical emergencies and related 30-day mortality rates were determined for a period refecting the peak pandemic of the frst wave in all participating countries (i.e. March 16th–April 15th, 2020), and compared to the same period in prior years (2017, 2018, and 2019).A total of 4,752 emergency neurosurgical cases were reviewed over a 4-year period. In 2020, during the COVID-19 pandemic, there was a general decline in the incidence of non-elective neurosurgical cases, which was driven by a reduced number of traumatic brain injuries, spine conditions, and chronic subdural hematomas. Thirty-day mortality did not signifcantly increase overall or for any of the conditions examined during the peak of the pandemic.The neurosurgical community in these three European countries observed a decrease in the incidence of some neurosurgical emergencies with 30-day mortality rates comparable to previous years (2017–2019). Lower incidence of neurosurgical cases is likely related to restrictions placed on mobility within countries, but may also involve delayed patient presentation.Medicine, Faculty ofOther UBCNon UBCReviewedFacultyResearcherPostdoctora