Quality of Life and Clinical Evaluation of Calcaneoplasty with a Balloon System for Calcaneal Fracture at 5 Years of Follow-Up

Calcaneal fractures are a challenging clinical problem. Management of this type of injury remains controversial, especially in the context of intra-articular fractures. Surgical treatment with open reduction and internal synthesis (ORIF) is considered the standard treatment for CF, but it is associated with many complications. Several minimally invasive techniques such as balloon-assisted reduction, pin fixation, and tricalcium phosphate augmentation have been proposed to avoid the frequent and recurrent postoperative problems related to these fractures. We retrospectively examined 20 patients (mean age was 54.5), all undergoing minimally invasive calcaneoplasty surgery at our Department of Orthopaedics and Traumatology between 2012 and 2016. X-ray and CT scan were performed preoperatively and at 5 years of follow-up (57.9 ± 6 months). The American Orthopaedic Foot and Ankle Society (AOFAS) score was used for clinical examination, and the Short-Form (36) Health Survey (SF-36) score and Visual Analogue Scale (VAS) were used to assess the Health-Related Quality of Life (HRQoL). All 20 patients were available at the final follow-up. The mean AOFAS score was 82.25/100. The VAS results attest an overall average of 2.7/10 (0–9). The average of the parameters “Physical Health” and “Mental Health” was, respectively, 81.25 and 83.55. In terms of postoperative complications, we observed no cases of superficial or deep infections. Clinical response after balloon-assisted reduction, pin fixation, and tricalcium phosphate augmentation has shown a comparable or better outcome according to the AOFAS and VAS score. Quality-of-life scores, obtained according to the SF-36 questionnaire, are considered high. From both a clinical and quality-of-life point of view, our study highlights that there is not gender distinction. Further comparative studies with a higher number of patients are needed which assess the quality of life in the various techniques used to treat calcaneal fractures

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P<0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)

SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study

Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. Methods The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18-49, 50-69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. Results NNVs were more favourable in surgical patients than the general population. The most favourable NNVs were in patients aged 70 years or more needing cancer surgery (351; best case 196, worst case 816) or non-cancer surgery (733; best case 407, worst case 1664). Both exceeded the NNV in the general population (1840; best case 1196, worst case 3066). NNVs for surgical patients remained favourable at a range of SARS-CoV-2 incidence rates in sensitivity analysis modelling. Globally, prioritizing preoperative vaccination of patients needing elective surgery ahead of the general population could prevent an additional 58 687 (best case 115 007, worst case 20 177) COVID-19-related deaths in 1 year. Conclusion As global roll out of SARS-CoV-2 vaccination proceeds, patients needing elective surgery should be prioritized ahead of the general population.The aim of this study was to inform vaccination prioritization by modelling the impact of vaccination on elective inpatient surgery. The study found that patients aged at least 70 years needing elective surgery should be prioritized alongside other high-risk groups during early vaccination programmes. Once vaccines are rolled out to younger populations, prioritizing surgical patients is advantageous