European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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The Minimal Clinically Important Difference (MCID) is crucial to evaluate management outcomes, but different thresholds have been obtained in different works. Part of this variability is due to measurement error and influence of the database, both essential for calculating the MCID. The aim of this study was to introduce the association of the ROC method in the anchor-based MCID calculation for ODI, SRS-22r, and SF-36, to objectively set the threshold for the anchor-based MCID in an adult spine deformity (ASD) population. ⋯ II.
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FDA investigational device exemption (IDE) studies are considered a gold standard of assessing safety and efficacy of novel devices through RCTs. The fragility index (FI) has emerged as a means to assess robustness of statistically significant study results and inversely, the reverse fragility index (RFI) for non-significant differences. Previous authors have defined results as fragile if loss to follow up is greater than the FI or RFI. The aim of this study was to assess the FI, RFI, and robustness of data supplied by IDE studies in spinal surgery. ⋯ IDE studies in spine surgery are surprisingly fragile given their reputations, large sample sizes, and intent to establish safety in investigational devices. This study found a median FI and RFI of 6. The number of patients lost to follow-up was greater than FIand RFI in 98.8% (237/240) of reported outcomes. FQ and RFQ tell us that changes of two to three patients per hundred can flip the significance of reported outcomes. This is an important reminder of the limitations of RCTs. Analysis of fragility in future studies may help clarify the strength of the relationship between reported data and their conclusions.
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Review Case Reports
Abdominal lymphocele following multi-level anterior lumbar interbody fusion (ALIF) managed with a laparoscopic peritoneal window: case report and review of the literature.
Lymphocele formation following anterior lumbar interbody fusion (ALIF) is not common, but it can pose diagnostic and treatment challenges. The purpose of this case is to report for the first time the treatment of a postoperative lymphocele following a multi-level ALIF using a peritoneal window made through a minimally invasive laparoscopic approach. ⋯ In this case report, creation of a peritoneal window minimally invasively via a laparoscope allowing passive drainage of lymphatic fluid into the abdomen was safe and effective for management of an abdominal lymphocele following a multi-level ALIF.
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Operative treatment of adult spinal deformity (ASD) has been shown to improve patient health-related quality of life (HRQOL). Selection of the uppermost instrumented vertebra (UIV) in either the upper thoracic (UT) or lower thoracic (LT) spine is a pivotal decision with effects on operative and postoperative outcomes. This review overviews the multifaceted decision-making process for UIV selection in ASD correction. ⋯ The correct selection of the UIV in surgical planning is a challenging task, which requires attention to preoperative alignment, patient comorbidities, clinical characteristics, available resources, and surgeon-specific factors such as experience.
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Review Case Reports
Post-operative epidural haematoma as complication of overconsumption of dried fruit in lumbar spinal surgery a case report and review of the literature.
Mebos, a traditional South Africa confection consisting of dried, pulped, and sugared apricots, is rich in fibre and vitamins, but also contains salicylic acid, flavonoids, and citric acid. We report a case of postoperative surgical site bleeding in a healthy patient who consumed approximately 2 kg of mebos per day prior to his elective spinal surgery. ⋯ Results highlighted the effect of flavonoids and citric acid and therefore explain the abnormal clotting profile in this patient. Inhibition of coagulation prior to elective surgery is a known contraindication and may pose great risks in spinal surgery. In the present report, we demonstrated an association between inhibition of coagulation and an excess of the flavonoids content and citric acid concentration in mebos consumed in the days prior to elective spinal surgery.