Introducing new implants and imaging techniques for lumbar spinal stenosis

The main objective of this thesis is to compare bony decompression with implantation of interspinous process devices (IPDs) in patients with intermittent neurogenic claudication (INC) caused by lumbar spinal stenosis (LSS). A national survey among Dutch spine surgeons is presented about the usual care of patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Surgeons' expectations of different treatment options are presented. The existing evidence on interspinous implant surgery will be systematically reviewed. Results of treatment with IPDs are compared with other (conservative) treatment options. The Foraminal Enlargement Lumbar Interspinosus distraXion (FELIX) trial is described. This double-blind, multicenter, randomized (cost)effectiveness study was designed to answer the question whether treatment with IPDs would be more (cost) effective compared with conventional bony decompression. Short-term results (eight weeks), long-term results (one and two year) and results in different subgroups are described in this thesis. The analysis based on total direct and indirect costs of both procedures (treatment with IPD and bony decompression) are also presented. INC suitable for surgical treatment. The compression on MR images was evaluated and correlated with baseline complaints and long-term clinical outcome.Paradigm spine/InspineUBL - phd migration 201

Pathogens of common wasps in their native and invaded range.

The clinical introduction of novel medical devices often occurs without evidence of good methodological quality and with relatively little oversight and regulation. As a consequence, the safety, efficacy, and long-term effects of devices are frequently insufficiently known upon device approval. Recent controversies surrounding the Poly Implant Prothese (PIP) breast implants, metal-on-metal hip implants, and interspinous implants underscore the need to reconsider how innovation in medical devices can adhere to sound ethical standards without inhibiting surgical research and development. In this article, the introduction of spinal implants is taken as an example to firstly discuss the scientific and ethical challenges of developing, testing, and introducing novel medical devices and to secondly identify avenues for improving the existing regulatory frameworks for such innovation. Two measures for improvement are most feasible in the short term: demanding prospective studies before device introduction and developing registries to monitor and evaluate new medical devices. LEVEL OF EVIDENCE: 5

Decompression with or without concomitant fusion in lumbar stenosis due to degenerative spondylolisthesis: a systematic review

PURPOSE:The primary objective of this systematic review is to compare the outcome after decompression with and without concomitant instrumented fusion in patients with lumbar stenosis and degenerative spondylolisthesis. Does adding fusion to simple decompression lead to better results?METHODS:PubMed, Embase, CENTRAL, Cochrane, Web of Science, CINAHL and Academic Search Premier were searched. All studies comparing outcome of decompression alone to decompression with concomitant-instrumented fusion in patients suffering from symptomatic lumbar stenosis with degenerative spondylolisthesis were included. Risk of bias was assessed using an adapted version of the Cowley checklist.RESULTS:Eleven studies were included in the analysis involving 3119 patients in total. In the majority of studies, including two RCTs, clinical outcome of both patient groups was comparable regarding most clinical outcome measures.CONCLUSION:Currently there is not enough evidence that adding instrumented fusion to a decompression leads to superior outcomes compared to decompression only in patients with lumbar stenosis and degenerative spondylolisthesis. The most important clinical outcome measures, including the ODI, show comparable results. Therefore, the least invasive and least costly procedure, being decompression alone, is preferred in patients with low-grade spondylolisthesis with predominant leg pain. These slides can be retrieved under Electronic Supplementary Material.Stem cells & developmental biolog

Outcomes of retreatment for intracranial aneurysms - a meta-analysis

Long term results from the International Subarachnoid Hemorrhage Trial (ISAT) and Barrow Ruptured Aneurysm Trial (BRAT) indicate considerably higher retreatment rates for aneurysms treated with coiling compared to clipping, but do not report the outcome of retreatment. The aim of this meta-analysis was to evaluate retreatment related outcomes.A meta-analysis in accordance with PRISMA guidelines was conducted using Medline search engines PubMed and EMBASE to identify articles describing outcomes after retreatment for intracranial aneurysms. Pooled prevalence rates for complete occlusion rate and mortality were calculated. Outcomes of different treatment and retreatment combinations were not compared because of indication bias. Twenty-five articles that met the inclusion criteria were included in the meta-analysis. Surgery after coiling had a pooled complete occlusion rate of 91.2% (95%-CI: 87.0-94.1) and a pooled mortality rate of 5.6% (95%-CI: 3.7-8.3). Coiling after coiling had a pooled complete occlusion rate of 51.3% (95%-CI: 22.1-78.0) and a pooled mortality rate of 0.8% (95%-CI: 0.15-3.7). Surgery after surgery did not provide a pooled estimate for complete occlusion as only one study was identified but had a pooled mortality rate of 5.9% (95%-CI: 3.1-11.2). Coiling after surgery had a pooled complete occlusion rate of 56.1% (95%-CI: 11.4- 92.7) and a pooled mortality rate of 9.3% (95%-CI: 4.1-19.9). All pooled incidence rates were produced using random-effect models.Conclusion:Surgical retreatment was associated with a high complete occlusion rate but considerable mortality. Conversely, endovascular retreatment was associated with low mortality but also a low complete occlusion rate. Scientific Assessment and Innovation in Neurosurgical Treatment Strategie

When Time Is Critical, Is Informed Consent Less So? A Discussion of Patient Autonomy in Emergency Neurosurgery

Neurosurgical interventions frequently occur in an emergency setting. In this setting, patients often have impaired consciousness and are unable to directly express their values and wishes regarding their treatment. The limited time available for clinical decision making has great ethical implications, as the informed consent procedure may become compromised. The ethical situation may be further challenged by different views between the patient, family members, and the neurosurgeon; the presence of advance directives; the use of an innovative procedure; or if the procedure is part of a research project. This moral opinion piece presents the implications of time constraints and a lack of patient capacity for autonomous decision making in emergency neurosurgical situations. Potential solutions to these challenges are presented that may help to improve ethical patient management in emergency settings. Emergency neurosurgery challenges the respect of autonomy of the patient. The outcome in most scenarios will rely on the neurosurgeon acting in a professional way to manage each unique situation in an ethically sound manner.Scientific Assessment and Innovation in Neurosurgical Treatment Strategie

SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis

Introduction Intermittent neurogenic claudication (INC) is often caused by lumbar spinal stenosis (LSS). Laminectomy is considered a frequently used surgical technique for LSS. Previous studies have shown that laminectomy can potentially cause lumbar instability. Less invasive techniques, preserving midline structures including the bilateral small size interarcuair decompression, are currently applied. Due to lack of evidence and consensus, surgeons have to rely on their training and own experiences to choose the best surgical techniques for their patients. Hence, an observer and patient blinded multicentre, randomised controlled trial was designed to determine the effectiveness and cost-effectiveness of bilateral interarcuair decompression versus laminectomy for LSS. Methods and analysis 174 patients above 40 years with at least 12 weeks of INC will be recruited. Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS. Patients will be randomised to laminectomy or bilateral interarcuair decompression. The primary outcome is functional status measured with the Roland-Morris Disability Questionnaire at 12 months. Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination. Outcome measurement moments will be scheduled at 3 and 6 weeks, and at 3, 6, 12, 18, 24, 36 and 48 months after surgery. Physical examination will be performed at 6 weeks, and 12, 24 and 48 months. An economic evaluation will be performed and questionnaires will be used to collect cost data. Ethics and dissemination The Medical Ethical Committee of the Erasmus Medical Centre Rotterdam approved this study (NL.65826.078.18). The results will be published in an international peer-reviewed journal

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: Randomized controlled trial

Abstract Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled trial. Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands. Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized. Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression. Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time. Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for

Practice variation research in degenerative lumbar disc surgery: a literature review on design characteristics and outcomes

Study Design: Literature review.Objective: To describe whether practice variation studies on surgery in patients with lumbar degenerative disc disease used adequate study methodology to identify unwarranted variation, and to inform quality improvement in clinical practice. Secondary aim was to describe whether variation changed over time.Methods: Literature databases were searched up to May 4th, 2021. To define whether study design was appropriate to identify unwarranted variation, we extracted data on level of aggregation, study population, and case-mix correction. To define whether studies were appropriate to achieve quality improvement, data were extracted on outcomes, explanatory variables, description of scientific basis, and given recommendations. Spearman's rho was used to determine the association between the Extreme Quotient (EQ) and year of publication.Results: We identified 34 articles published between 1990 and 2020. Twenty-six articles (76%) defined the diagnosis. Prior surgery cases were excluded or adjusted for in 5 articles (15%). Twenty-three articles (68%) adjusted for case-mix. Variation in outcomes was analyzed in 7 articles (21%). Fourteen articles (41%) identified explanatory variables. Twenty-six articles (76%) described the evidence on effectiveness. Recommendations for clinical practice were given in 9 articles (26%). Extreme Quotients ranged between 1-fold and 15-fold variation and did not show a significant change over time (rho= -.33, P= .09).Conclusions: Practice variation research on surgery in patients with degenerative disc disease showed important limitations to identify unwarranted variation and to achieve quality improvement by public reporting. Despite the availability of new evidence, we could not observe a significant decrease in variation over time.Otorhinolaryngolog

The DEXA-CORT trial: study protocol of a randomised placebo-controlled trial of hydrocortisone in patients with brain tumour on the prevention of neuropsychiatric adverse effects caused by perioperative dexamethasone

Introduction The synthetic glucocorticoid dexamethasone can induce serious neuropsychiatric adverse effects. Dexamethasone activates the glucocorticoid receptor (GR) but, unlike endogenous cortisol, not the mineralocorticoid receptor (MR). Moreover, dexamethasone suppresses cortisol production, thereby eliminating its MR binding. Consequently, GR overactivation combined with MR underactivation may contribute to the neuropsychiatric adverse effects of dexamethasone. The DEXA-CORT trial aims to reactivate the MR using cortisol to reduce neuropsychiatric adverse effects of dexamethasone treatment. Methods and analysis The DEXA-CORT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients who undergo elective brain tumour resection treated perioperatively with high doses of dexamethasone to minimise cerebral oedema. 180 patients are randomised between treatment with either two times per day 10 mg hydrocortisone or placebo during dexamethasone treatment. The primary study outcome is the difference in proportion of patients scoring >= 3 points on at least one of the Brief Psychiatric Rating Scale (BPRS) questions 5 days postoperatively or earlier at discharge. Secondary outcomes are neuropsychiatric symptoms, quality of sleep, health-related quality of life and neurocognitive functioning at several time points postoperatively. Furthermore, neuropsychiatric history, serious adverse events, prescribed (psychiatric) medication and referrals or evaluations of psychiatrist/psychologist and laboratory measurements are assessed. Ethics and dissemination The study protocol has been approved by the Medical Research Ethics Committee of the Leiden University Medical Center, and by the Dutch competent authority, and by the Institutional Review Boards of the participating sites. It is an investigator-initiated study with financial support by The Netherlands Organisation for Health Research and Development (ZonMw) and the Dutch Brain Foundation. Results of the study will be submitted for publication in a peer-reviewed journal.Diabetes mellitus: pathophysiological changes and therap