[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593456":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":43,"responsibleParty":245,"collaborators":247,"id":251,"slug":252,"hasResults":253,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":253,"sex":258,"minAge":259,"maxAge":260,"enrollmentInfo":261,"targetDuration":18,"studyType":264,"phases":265,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":46,"whyStopped":18,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},{"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",[44,61,72,88,101,120,133,146,159,175,191,202,215,228],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Eskenazi Hospital","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-86.15804,39.76838,{"lat":56,"lon":55},[59],{"name":60,"role":31,"phone":18,"phoneExt":18,"email":18},"Karl Shively, MD",{"facility":62,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Indiana University-Methodist",{"type":53,"coordinates":64},[55,56],{"lat":56,"lon":55},[67,70],{"name":68,"role":37,"phone":18,"phoneExt":18,"email":69},"Lauren Hill, BS","hilllc@iu.edu",{"name":71,"role":31,"phone":18,"phoneExt":18,"email":18},"Brian Mullis, MD",{"facility":73,"status":46,"city":74,"state":75,"zip":76,"country":50,"countryCode":51,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University of Maryland R Adams Cowley Shock Trauma Center","Baltimore","Maryland","21201",{"type":53,"coordinates":78},[79,80],-76.61219,39.29038,{"lat":80,"lon":79},[83,86],{"name":84,"role":37,"phone":18,"phoneExt":18,"email":85},"Yasmin Degani","ydegani@umoa.umm.edu",{"name":87,"role":31,"phone":18,"phoneExt":18,"email":18},"Robert O'Toole, MD",{"facility":89,"status":46,"city":90,"state":91,"zip":92,"country":50,"countryCode":51,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Harvard Medical Center","Cambridge","Massachusetts","02138",{"type":53,"coordinates":94},[95,96],-71.10561,42.3751,{"lat":96,"lon":95},[99],{"name":100,"role":31,"phone":18,"phoneExt":18,"email":18},"Michael Weaver, MD",{"facility":102,"status":46,"city":103,"state":104,"zip":105,"country":50,"countryCode":51,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Hennepin Health","Minneapolis","Minnesota","55487",{"type":53,"coordinates":107},[108,109],-93.26384,44.97997,{"lat":109,"lon":108},[112,116,118],{"name":113,"role":37,"phone":114,"phoneExt":18,"email":115},"Olutayo Alese","612-873-4634","olutayo.alese@hcmed.org",{"name":117,"role":31,"phone":18,"phoneExt":18,"email":18},"Andrew Schmidt, MD",{"name":119,"role":31,"phone":18,"phoneExt":18,"email":18},"Nancy Luger, MD",{"facility":121,"status":46,"city":122,"state":123,"zip":124,"country":50,"countryCode":51,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of Mississippi","Jackson","Mississippi","39216",{"type":53,"coordinates":126},[127,128],-90.18481,32.29876,{"lat":128,"lon":127},[131],{"name":132,"role":31,"phone":18,"phoneExt":18,"email":18},"Patrick Bergin, MD",{"facility":134,"status":46,"city":135,"state":136,"zip":137,"country":50,"countryCode":51,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"The MetroHealth System","Cleveland","Ohio","44109",{"type":53,"coordinates":139},[140,141],-81.69541,41.4995,{"lat":141,"lon":140},[144],{"name":145,"role":31,"phone":18,"phoneExt":18,"email":18},"Nicholas Romeo, MD",{"facility":147,"status":46,"city":148,"state":149,"zip":150,"country":50,"countryCode":51,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Allegheny General Hospital","Pittsburgh","Pennsylvania","15212",{"type":53,"coordinates":152},[153,154],-79.99589,40.44062,{"lat":154,"lon":153},[157],{"name":158,"role":31,"phone":18,"phoneExt":18,"email":18},"Gregory Altman, MD",{"facility":160,"status":46,"city":161,"state":162,"zip":163,"country":50,"countryCode":51,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Vanderbilt Medical Center","Nashville","Tennessee","37203",{"type":53,"coordinates":165},[166,167],-86.78444,36.16589,{"lat":167,"lon":166},[170,173],{"name":171,"role":37,"phone":18,"phoneExt":18,"email":172},"Karen Trochez","karen.m.trochez@vumc.org",{"name":174,"role":31,"phone":18,"phoneExt":18,"email":18},"William Obremskey, MD",{"facility":176,"status":46,"city":177,"state":178,"zip":179,"country":50,"countryCode":51,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"University of Texas Health Science Center - 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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":262,"type":263},1000,"ESTIMATED","INTERVENTIONAL",[266],"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.",[269,270],"Tibial Fractures","Pain",[272,273,274,275,256],"Ibuprofen","Pain Management","Tibia Fracture","IM Nail Fixation","2025-05-27",{"date":278,"type":279},"2025-06-05","ACTUAL",{"date":281,"type":279},"2021-05-26",{"date":283,"type":263},"2027-03",{"name":5,"class":6},14]