The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 106 PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%.Aims
Methods
The COVID-19 pandemic presents an unprecedented burden on global healthcare systems, and existing infrastructures must adapt and evolve to meet the challenge. With health systems reliant on the health of their workforce, the importance of protection against disease transmission in healthcare workers (HCWs) is clear. This study collated responses from several countries, provided by clinicians familiar with practice in each location, to identify areas of best practice and policy so as to build consensus of those measures that might reduce the risk of transmission of COVID-19 to HCWs at work. A cross-sectional descriptive survey was designed with ten open and closed questions and sent to a representative sample. The sample was selected on a convenience basis of 27 senior surgeons, members of an international surgical society, who were all frontline workers in the COVID-19 pandemic. This study was reported according to the Standards for Reporting Qualitative Research (SRQR) checklist.Aims
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