Evaluating Glenohumeral Osteoarthritis: The Relative Impact of Patient Age, Activity Level, Symptoms, and Kellgren-Lawrence Grade on Treatment

Background: It is not always clear how to treat glenohumeral osteoarthritis, particularly in young patients. The goals ofthis study were to 1) quantify how patient age, activity level, symptoms, and radiographic findings impact the decisionmakingof shoulder specialists and 2) evaluate the observer reliability of the Kellgren-Lawrence (KL) grading system forprimary osteoarthritis of the shoulder.Methods: Twenty-six shoulder surgeons were each sent 54 simulated patient cases. Each patient had a differentcombination of age, symptoms, activity level, and radiographs. Responders graded the radiographs and chose atreatment (non-operative, arthroscopy, hemiarthroplasty, or total shoulder arthroplasty). Spearman correlations andchi square tests were used to assess the relationship between factors and treatments. Sub-analysis was performedon surgical cases. An intra-class correlation (ICC) was used to assess observer agreement.Results: The significant correlations (

Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

BACKGROUND: Perinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia. METHODS: This study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24 months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age ≥ 36 weeks and a birth weight ≥ 2500 g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion. DISCUSSION: This trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia. TRIAL REGISTRATION: NCT03162653, www.ClinicalTrials.gov , May 22, 2017.status: publishe