[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053870":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A - Corticosteroid Injection","EXPERIMENTAL","Corticosteroid injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).\n\nThe patient will be brought to the regional room where a fully licensed anaesthesiologist will perform standard of care anaesthesia followed by an ultrasound guided intra-articular knee injection with steroid AFTER the spinal neuraxial blockage has already been administered.",[13],"Drug: Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B - Band-Aid Placement","SHAM_COMPARATOR","The patient will be brought to the regional room where a fellowship trained interventional pain\u002Fregional anaesthesiologist will perform standard of care anaesthesia followed by the application of a band-aid.",[19],"Other: Band-Aid",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Corticosteroid Injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).",[9],null,{"type":6,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"Band-Aid",[15],[30],{"name":31,"affiliation":5,"role":32},"Amir Khoshbin, MD, FRCS (C)","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Cassandra Tardif-Theriault, BKin","CONTACT","416-864-6060","77117","cassandra.tardif-theriault@unityhealth.to",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"St. Michael's Hospital","RECRUITING","Toronto","Ontario","M5B 1W8","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-79.39864,43.70643,{"lat":53,"lon":52},[56,59,60],{"name":31,"role":36,"phone":57,"phoneExt":25,"email":58},"416-864-5265","amir.khoshbin@unityhealth.to",{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100053870","phase-1-contralateral-corticosteroid-injection-in-total-knee-arthroplasty-100053870",false,"NCT06809998","COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty","COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study","COSTI","Inclusion Criteria:\n\n* Patients 18 years of age and older\n* Primary osteoarthritis diagnosis with indication for primary elective unilateral TKA\n* No previous contralateral knee injections (steroids\u002Fbiologics) within one year of study\n* Not scheduled for bilateral TKA or a subsequent staged contralateral TKA within the next six months\n* No previous or active infection or trauma (osseous\u002Fligamentous\u002Fextensor mechanism) on the contralateral knee\n* Contralateral knee pain \\& symptoms - defined as a VAS of \\>4\u002F10 at initial pre-op visit\n* Contralateral knee OA quantified as: Kellgren and Lawrence grade \\>2-4\n\n  * Assessed by PI (AK) who will not be contributing any patients to the study through examination of blinded knee radiographs (3 views: AP\u002Flateral\u002FSunrise)\n* Patient is able to read and understand English and provide informed consent to participation in the study\n\nExclusion Criteria:\n\n* Other aetiologies of OA that warrants TKA (inflammatory or post traumatic arthritis)\n* Cognitive impairment (dementia, Alzheimer's, uncontrolled delirium) which will prevent patients from completing primary outcome measure or comply with follow-up requirements\n* Previous TKA or ORIF or nailing on either knee\n* Previous or active knee infection or extensor mechanism disruption\n* Previous arthroscopy on either knee\n* Medical contraindication to elective TKA surgery","ALL","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.",[82,83,84,85],"Total Knee Anthroplasty","Osteoarthritis(Primary)","Osteoarthritis (OA) of the Knee","Bilateral Knee Osteoarthritis",[69,87,88],"Total Knee Arthroplasty","Corticosteroid Injection","2026-07-09",{"date":91,"type":92},"2026-07-13","ACTUAL",{"date":94,"type":92},"2025-01-24",{"date":96,"type":75},"2027-08-30",{"name":5,"class":6},1]