[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588078":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":31,"responsibleParty":50,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":31,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":31,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":81,"whyStopped":31,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":31},{"fullName":5,"class":6},"Geisinger Clinic","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Colchicine Loading Dose Only","EXPERIMENTAL","Patients in this arm will receive 1.8 mg of colchicine on postoperative day 0. This dosage aligns with standard of care loading dose for acute gout attacks. This will be a one time dosage of colchicine. On postoperative days 1-3, patients will take placebo dextrose pills twice daily.",[13],"Drug: Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Colchicine Loading Dose + Maintenance Dose","Patients in this arm will receive a 1.8 mg loading dose of colchicine on postoperative day 0. They will then take a 0.6 mg maintenance dose twice daily on postoperative days 1-3. This dosage of colchicine in this arm models standard of care dosing for acute gout attacks.",[18],"Drug: Colchicine 1.8 mg + 0.6 mg",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Group","PLACEBO_COMPARATOR","Patients in this arm will receive a placebo dextrose pill on postoperative day 0. They will then take a placebo dextrose pill twice daily on postoperative days 1-3.",[24],"Drug: Dextrose Oral Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Colchicine 1.8 mg (loading dose) + Dextrose Oral Placebo","This intervention will be used for individuals in arm A of the study who will receive a loading dose of colchicine (1.8 mg) on postoperative day 0, and will then be given placebo oral dextrose pills to take twice daily on postoperative days 1-3",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Colchicine 1.8 mg + 0.6 mg","This intervention is will be given to patients in arm B of the study who will receive a loading dose of colchicine (1.8 mg) on postoperative day 0, followed by a maintenance does of colchicine (0.6 mg) to be taken twice daily on postoperative days 1-3.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Dextrose Oral Placebo","This intervention will be for patients in arm C, the placebo arm. These patients will receive oral dextrose pills to be taken once on postoperative day 0, and twice daily on postoperative days 1-3.",[20],[41,46],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Ian Barr Medical Student, MS-2, BS","CONTACT","814-404-6616","ibarr1@som.geisinger.edu",{"name":47,"role":43,"phone":48,"phoneExt":31,"email":49},"John Mercuri Principal Investigator, MD","570-961-3823","Jmercuri1@geisinger.edu",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","John Mercuri, MD","Medical Doctor",[55],{"name":56,"class":6},"St. Luke's Hospital, Kansas City, Missouri","100588078","phase-4-perioperative-colchicine-for-tka-100588078",false,"NCT06936709","Perioperative Colchicine for TKA","Effect of Colchicine in the Perioperative Period on Reducing Post-Operative Pain in Total Knee Arthroplasty","Inclusion Criteria:\n\n* Patients 18 years or older undergoing elective total knee arthroplasty for osteoarthritis.\n\nExclusion Criteria:\n\n* Subject has impaired hepatic function (Child-Pugh Class \\>B)\n* Subject has impaired renal function (GFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2)\n* Subject has known adverse reaction to colchicine\n* Subject has chronic opioid use (Filled opioid medication twice within 6 months of surgical date)\n* Subject is pregnant or expecting to become pregnant during the time of the study associated with colchicine exposure (postoperative days 0-3)\n* Subject is unable to provide informed consent\n* Subject is actively prescribed medication that interact with colchicine in a manner that would increase the risk of colchicine toxicity, i.e.:\n* Antifungals: Ketoconazole, itraconazole, fluconazole, etc…\n* Macrolides : Clarithromycin, erythromycin\n* HIV protease : Ritonavir, Atazanavir, saquinavir, etc...\n* Ca2+: Verapamil and Diltiazem\n* Cyclosporine\n* Danazol\n* Amiodorone\n* Quinidine\n* Anti-hepaciviral combinations\n* Grapefruit juice\n* Statins: atorvastatin, lovastatin, simvastatin, etc…\n* Gemfibrozil and other fibrates\n* Digoxin","ALL","18 Years",{"count":67,"type":68},75,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","This study is a prospective, randomized, double-blinded, placebo-controlled study of the drug colchicine in the acute postoperative period for patients who are undergoing a total knee arthroplasty (TKA). Patients aged 18 years or older who are undergoing TKA will be invited to participate in the study. The primary endpoint of this study is to determine if colchicine, an anti-inflammatory medication commonly used for gout attacks, will decrease the postoperative pain of patients undergoing elective TKA.",[74,75,76],"Osteoarthritis of Knee","Recovery Following Primary Total Knee Arthroplasty","Perioperative Pain Control",[78,79,80],"Total Knee Arthroplasty","Colchicine","Postoperative Pain","NOT_YET_RECRUITING","2025-08-15",{"date":84,"type":85},"2025-08-17","ACTUAL",{"date":87,"type":68},"2025-12-01",{"date":89,"type":68},"2026-03-01",{"name":5,"class":6}]