[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593456":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":43,"responsibleParty":243,"collaborators":245,"id":249,"slug":18,"hasResults":250,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":250,"sex":255,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":18,"studyType":261,"phases":262,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":46,"whyStopped":18,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},{"fullName":5,"class":6},"Major Extremity Trauma Research Consortium","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care Pain Management with NSAIDs","ACTIVE_COMPARATOR","Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.",[13],"Drug: 600 mg Ibuprofen",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Pain Management without NSAIDs","NO_INTERVENTION","Control patients will receive standard of care pain medication regimen and may not use NSAIDs. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","600 mg Ibuprofen",[9],[25,26],"Advil","Motrin",[28,32],{"name":29,"affiliation":30,"role":31},"Thomas Higgins, MD","University of Utah","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Renan Castillo, PhD","Johns Hopkins University",[36,40],{"name":29,"role":37,"phone":38,"phoneExt":18,"email":39},"CONTACT","801-870-113","thomas.higgins@hsc.utah.edu",{"name":41,"role":37,"phone":18,"phoneExt":18,"email":42},"Katherine Frey, PhD","kparris1@jhu.edu",[44,60,71,87,100,119,132,145,158,174,190,201,214,227],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Eskenazi Hospital","RECRUITING","Indianapolis","Indiana","46202","United States",{"type":52,"coordinates":53},"Point",[54,55],-86.15804,39.76838,{"lat":55,"lon":54},[58],{"name":59,"role":31,"phone":18,"phoneExt":18,"email":18},"Karl Shively, MD",{"facility":61,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Indiana University-Methodist",{"type":52,"coordinates":63},[54,55],{"lat":55,"lon":54},[66,69],{"name":67,"role":37,"phone":18,"phoneExt":18,"email":68},"Lauren Hill, BS","hilllc@iu.edu",{"name":70,"role":31,"phone":18,"phoneExt":18,"email":18},"Brian Mullis, MD",{"facility":72,"status":46,"city":73,"state":74,"zip":75,"country":50,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University of Maryland R Adams Cowley Shock Trauma Center","Baltimore","Maryland","21201",{"type":52,"coordinates":77},[78,79],-76.61219,39.29038,{"lat":79,"lon":78},[82,85],{"name":83,"role":37,"phone":18,"phoneExt":18,"email":84},"Yasmin Degani","ydegani@umoa.umm.edu",{"name":86,"role":31,"phone":18,"phoneExt":18,"email":18},"Robert O'Toole, MD",{"facility":88,"status":46,"city":89,"state":90,"zip":91,"country":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Harvard Medical Center","Cambridge","Massachusetts","02138",{"type":52,"coordinates":93},[94,95],-71.10561,42.3751,{"lat":95,"lon":94},[98],{"name":99,"role":31,"phone":18,"phoneExt":18,"email":18},"Michael Weaver, MD",{"facility":101,"status":46,"city":102,"state":103,"zip":104,"country":50,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Hennepin Health","Minneapolis","Minnesota","55487",{"type":52,"coordinates":106},[107,108],-93.26384,44.97997,{"lat":108,"lon":107},[111,115,117],{"name":112,"role":37,"phone":113,"phoneExt":18,"email":114},"Olutayo Alese","612-873-4634","olutayo.alese@hcmed.org",{"name":116,"role":31,"phone":18,"phoneExt":18,"email":18},"Andrew Schmidt, MD",{"name":118,"role":31,"phone":18,"phoneExt":18,"email":18},"Nancy Luger, MD",{"facility":120,"status":46,"city":121,"state":122,"zip":123,"country":50,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"University of Mississippi","Jackson","Mississippi","39216",{"type":52,"coordinates":125},[126,127],-90.18481,32.29876,{"lat":127,"lon":126},[130],{"name":131,"role":31,"phone":18,"phoneExt":18,"email":18},"Patrick Bergin, MD",{"facility":133,"status":46,"city":134,"state":135,"zip":136,"country":50,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"The MetroHealth System","Cleveland","Ohio","44109",{"type":52,"coordinates":138},[139,140],-81.69541,41.4995,{"lat":140,"lon":139},[143],{"name":144,"role":31,"phone":18,"phoneExt":18,"email":18},"Nicholas Romeo, MD",{"facility":146,"status":46,"city":147,"state":148,"zip":149,"country":50,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Allegheny General Hospital","Pittsburgh","Pennsylvania","15212",{"type":52,"coordinates":151},[152,153],-79.99589,40.44062,{"lat":153,"lon":152},[156],{"name":157,"role":31,"phone":18,"phoneExt":18,"email":18},"Gregory Altman, MD",{"facility":159,"status":46,"city":160,"state":161,"zip":162,"country":50,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Vanderbilt Medical Center","Nashville","Tennessee","37203",{"type":52,"coordinates":164},[165,166],-86.78444,36.16589,{"lat":166,"lon":165},[169,172],{"name":170,"role":37,"phone":18,"phoneExt":18,"email":171},"Karen Trochez","karen.m.trochez@vumc.org",{"name":173,"role":31,"phone":18,"phoneExt":18,"email":18},"William Obremskey, MD",{"facility":175,"status":46,"city":176,"state":177,"zip":178,"country":50,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"University of Texas Health Science Center - Houston","Houston","Texas","77030",{"type":52,"coordinates":180},[181,182],-95.36327,29.76328,{"lat":182,"lon":181},[185,188],{"name":186,"role":37,"phone":18,"phoneExt":18,"email":187},"Sterling Boutte","Sterling.Boutte@uth.tmc.edu",{"name":189,"role":31,"phone":18,"phoneExt":18,"email":18},"Stephen Warner, MD",{"facility":30,"status":46,"city":191,"state":192,"zip":193,"country":50,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Salt Lake City","Utah","84108",{"type":52,"coordinates":195},[196,197],-111.89105,40.76078,{"lat":197,"lon":196},[200],{"name":29,"role":31,"phone":18,"phoneExt":18,"email":18},{"facility":202,"status":46,"city":203,"state":204,"zip":205,"country":50,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Inova Fairfax Hospital","Falls Church","Virginia","22042",{"type":52,"coordinates":207},[208,209],-77.17109,38.88233,{"lat":209,"lon":208},[212],{"name":213,"role":31,"phone":18,"phoneExt":18,"email":18},"Greg Gaski, MD",{"facility":215,"status":46,"city":216,"state":217,"zip":218,"country":50,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"University of Wisconsin","Madison","Wisconsin","53705",{"type":52,"coordinates":220},[221,222],-89.40123,43.07305,{"lat":222,"lon":221},[225],{"name":226,"role":31,"phone":18,"phoneExt":18,"email":18},"Chris Domes, MD",{"facility":228,"status":46,"city":229,"state":230,"zip":18,"country":231,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"University of Calgary, Foothills Medical Centre","Calgary","Alberta","Canada",{"type":52,"coordinates":233},[234,235],-114.08529,51.05011,{"lat":235,"lon":234},[238,241],{"name":239,"role":37,"phone":18,"phoneExt":18,"email":240},"Prim Schneider, MD","prism.schneider@gmail.com",{"name":242,"role":31,"phone":18,"phoneExt":18,"email":18},"Prism Schneider, MD",{"type":244,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[246],{"name":247,"class":248},"United States Department of Defense","FED","100593456",false,"NCT07006675","Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial","NSAID","Inclusion Criteria:\n\n1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.\n2. Patients 18-80 years old inclusive.\n3. Patients able to be followed at a METRC facility for at least 12 months following injury\n\nExclusion Criteria:\n\n1. Patient unable to provide informed consent\n2. Patients who are current - intravenous drug user.\n3. Patients with a history of allergy to the study drugs.\n4. Patients unable to swallow oral medications or without functioning GI tract.\n5. Patients with a history of gastrointestinal bleeds or gastric perforation.\n6. Patients with a history of stroke or heart attack.\n7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.\n8. Patients with any bleeding disorders.\n9. Patients with severe renal failure \\[GFR:\\\u003C30\\]. Patients with moderate renal failure \\[GFR: 30-59\\] may participate in the study at a modified dose \\[see section 8.6 for defined modified dose\\].\n10. Patients undergoing daily treatment with systemic glucocorticoids before surgery.\n11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.\n12. Patients with a GCS \\\u003C15 at discharge.\n13. Patients with a closed head injury that precludes NSAIDS.\n14. Patients who are pregnant or lactating at time of screening\n15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.","ALL","18 Years","80 Years",{"count":259,"type":260},1000,"ESTIMATED","INTERVENTIONAL",[263],"PHASE3","Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.",[266,267],"Tibial Fractures","Pain",[269,270,271,272,253],"Ibuprofen","Pain Management","Tibia Fracture","IM Nail Fixation","2025-05-27",{"date":275,"type":276},"2025-06-05","ACTUAL",{"date":278,"type":276},"2021-05-26",{"date":280,"type":260},"2027-03",{"name":5,"class":6},14]