[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395662":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":69,"collaborators":23,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":23,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":23,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":55,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Ente Ospedaliero Cantonale, Bellinzona","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"arm-A Intra-venous dexamethasone","EXPERIMENTAL","9 mg of Intra-venous dexamethasone",[13],"Drug: Dexamethasone Sodium Phosphate 4 mg\u002Fml intravenous",{"label":15,"type":10,"description":16,"interventionNames":17},"arm-B intra-articular dexamethasone","9 mg of intra-articular dexamethasone",[18],"Drug: Dexamethasone Sodium Phosphate 4 mg\u002Fml intra-articular",{"label":20,"type":21,"description":22,"interventionNames":23},"arm-C routine","NO_INTERVENTION","No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group",null,[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Dexamethasone Sodium Phosphate 4 mg\u002Fml intravenous","Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)",[9],[31],"Mephameson",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Dexamethasone Sodium Phosphate 4 mg\u002Fml intra-articular","Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)",[15],[31],[38],{"name":39,"affiliation":40,"role":41},"Christian Candrian, MD, Prof.","EOC","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},"Christian Candrian, MD, Prof","CONTACT","+41 (0) 91 811 61 23","christian.candrian@eoc.ch",{"name":49,"role":45,"phone":50,"phoneExt":23,"email":51},"Marco Delcogliano, MD","+41 (0)91 811 66 56","marco.delcogliano@eoc.ch",[53],{"facility":54,"status":55,"city":56,"state":23,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Ospedale Regionale di Lugano Civico e Italiano","RECRUITING","Lugano","6900","Switzerland","CH",{"type":61,"coordinates":62},"Point",[63,64],8.96004,46.01008,{"lat":64,"lon":63},[67],{"name":44,"role":45,"phone":68,"phoneExt":23,"email":47},"+41 (0)91 811 7029",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Christian Candrian","Principal Investigator","100395662","phase-4-a-study-to-compare-different-ways-of-steroid-administration-after-total-knee-implantation-100395662",false,"NCT04432012","A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation","Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol","Inclusion Criteria:\n\n* Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.\n* Patients with a BMI \\>18.5 and \\\u003C35.\n* Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.\n* Informed Consent as documented by signature (Appendix Informed Consent Form).\n\nExclusion Criteria:\n\n* Contraindications to steroids.\n* Revision TKA.\n* Active steroid therapy.\n* Women who are pregnant or breast feeding.\n* Presence of other clinically significant concomitant disease states (ASA IV).\n* Uncontrolled diabetes mellitus\n* Known or suspected non-compliance, drug or alcohol abuse.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* Participation in another study with investigational drug within the 30 days preceding and during the present study.\n* Previous enrolment into the current study.\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons.","ALL","50 Years","85 Years",{"count":84,"type":85},159,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.",[91],"Total Knee Replacement",[93,94,95,96],"Knee","surgery","replacement","arthroplasty","2025-08-05",{"date":99,"type":100},"2025-08-06","ACTUAL",{"date":102,"type":100},"2020-07-01",{"date":104,"type":85},"2033-04-30",{"name":71,"class":6},1]