[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450553":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":113,"collaborators":10,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":10,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":10,"enrollmentInfo":125,"targetDuration":10,"studyType":128,"phases":10,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-surgical group",null,"Patients will receive analgesia and symptomatic management treatment",[13],"Device: Non surgical and 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Health)","Melbourne","Victoria","31004",{"type":45,"coordinates":76},[77,78],144.96332,-37.814,{"lat":78,"lon":77},[81],{"name":26,"role":32,"phone":10,"phoneExt":10,"email":82},"S.Marasco@alfred.org.au",{"facility":84,"status":56,"city":85,"state":86,"zip":87,"country":88,"countryCode":10,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Yonsei Wonju Severance Christian Hospital","Wŏnju","Gangwon-do","26426","South Korea",{"type":45,"coordinates":90},[91,92],127.94528,37.35139,{"lat":92,"lon":91},[95,97],{"name":96,"role":32,"phone":10,"phoneExt":10,"email":10},"Chun",{"name":98,"role":28,"phone":10,"phoneExt":10,"email":10},"Sung Byun Chun",{"facility":100,"status":56,"city":101,"state":102,"zip":103,"country":88,"countryCode":10,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Ajou University Hospital","Suwon","Gyeonggi-do","16499",{"type":45,"coordinates":105},[106,107],127.00889,37.29111,{"lat":107,"lon":106},[110,112],{"name":111,"role":32,"phone":10,"phoneExt":10,"email":10},"Jong Hwan Moon",{"name":111,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":114,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100450553","ribfix-blu-thoracic-fixation-system-versus-non-surgical-treatment-in-non-flail-chest-rib-fractures-100450553",false,"NCT05146986","RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures","Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures","Inclusion Criteria:\n\n* Age 18 and above (inclusive)\n* Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements\n* Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)\n* Willing and able to complete scheduled follow-up evaluations as described in the study protocol\n* Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB\u002FEC) approved Patient Information\u002F Informed consent Form (PICF)\n\nExclusion Criteria:\n\n* Flail chest rib fractures based on radiological or clinical findings\n* Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma\n* Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery\n* Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest\n* Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome\n* Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:\n\n  * Spanning a midline sternotomy\n  * Active Infection\n  * Foreign body sensitivity\n* Is known to be pregnant\n* Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.\n* Participation in another surgical intervention that may influence any of the outcome parameters.",true,"ALL","18 Years",{"count":126,"type":127},167,"ESTIMATED","OBSERVATIONAL","This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.",[131],"Rib; Fracture",[133],"Non-flail chest","2024-03-05",{"date":136,"type":137},"2024-03-07","ACTUAL",{"date":139,"type":137},"2022-01-02",{"date":141,"type":127},"2026-12-30",{"name":5,"class":6},5]