[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457034":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual mini-fragment plating","EXPERIMENTAL",null,[13],"Procedure: Dual Mini-fragment Plating",{"label":15,"type":16,"description":11,"interventionNames":17},"Single precontoured plating","ACTIVE_COMPARATOR",[18],"Procedure: Single Precontoured Plating",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Dual Mini-fragment Plating","Patients randomized to dual mini-fragment plating will undergo clavicle fixation using any configuration of 2.0-mm, 2.4-mm and 2.7-mm limited contact dynamic compression (LC-DCP), locking compression (LCP) or reconstruction plates (i.e., 2.4-mm superior and 2.7-mm anteroinferior). One of the two plates used must be a LC-DCP or LCP plate. Surgeons will contour the mini-fragment plate intraoperatively to fit each patient's anatomy.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Single Precontoured Plating","Patients randomized to a single plate construct will undergo fixation using an anatomically precontoured (superior or anterior-inferior) clavicle plate.",[15],[30],{"name":31,"affiliation":5,"role":32},"Ujash Sheth, MD MSc FRCSC","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Sara Aman, BSc","CONTACT","416-480-4285","orthores@sunnybrook.ca",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},"Katrine Milner, BSc","katrine.milner@sunnybrook.ca",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-79.39864,43.70643,{"lat":54,"lon":53},[57,59,60],{"name":58,"role":36,"phone":37,"phoneExt":11,"email":38},"Alicia Alvares, BSc",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Dr. Ujash Sheth","Orthopaedic Surgeon",[65],{"name":66,"class":6},"Canadian Orthopaedic Trauma Society","100457034","comparing-dual-mini-fragment-plating-to-single-precontoured-plating-of-acute-midshaft-clavicle-fractures-trial-100457034",false,"NCT05231343","Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial","A Prospective Randomized Trial Comparing Dual Mini-Fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures: A Pilot Study","COMPACT","Inclusion Criteria:\n\n* Between 18 and 65 years of age\n* A completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments (AO\u002FOTA 15.2A\u002FB\u002FC)\n* Fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment\n\nExclusion Criteria:\n\n* Open fracture\n* Pathological fracture\n* Fracture seen \\> 28 days after injury\n* Associated neurovascular injury\n* Associated head injury (Glasgow Coma Scale \\\u003C 12)\n* Concomitant ipsilateral upper extremity fracture\n* Significant medical comorbidities (i.e., ASA grade IV and V)\n* Inability to comply with follow-up and\n* Lack of consent","ALL","18 Years","65 Years",{"count":79,"type":80},66,"ESTIMATED","INTERVENTIONAL",[83],"NA","The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.",[86],"Clavicle Fracture",[88,89,90],"Orthogonal plating","Hardware removal","Reoperation","2023-05-22",{"date":93,"type":94},"2023-05-24","ACTUAL",{"date":96,"type":94},"2022-04-04",{"date":98,"type":80},"2028-01",{"name":5,"class":6},1]