[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450553":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":112,"collaborators":10,"id":114,"slug":10,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":10,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":10,"enrollmentInfo":123,"targetDuration":10,"studyType":126,"phases":10,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"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 Surgical",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgical group","Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Non surgical and Surgical","For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment).\n\nFor surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Silvana Marasco, Professor","The Alfred","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Irene Chong","CONTACT","97566687","irene.chong@zimmerbiomet.com",[36,53,69,82,98],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hunter New England Health District","NOT_YET_RECRUITING","Sydney","New South 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Health)","Melbourne","Victoria","31004",{"type":44,"coordinates":75},[76,77],144.96332,-37.814,{"lat":77,"lon":76},[80],{"name":26,"role":32,"phone":10,"phoneExt":10,"email":81},"S.Marasco@alfred.org.au",{"facility":83,"status":55,"city":84,"state":85,"zip":86,"country":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Yonsei Wonju Severance Christian Hospital","Wŏnju","Gangwon-do","26426","South Korea",{"type":44,"coordinates":89},[90,91],127.94528,37.35139,{"lat":91,"lon":90},[94,96],{"name":95,"role":32,"phone":10,"phoneExt":10,"email":10},"Chun",{"name":97,"role":28,"phone":10,"phoneExt":10,"email":10},"Sung Byun Chun",{"facility":99,"status":55,"city":100,"state":101,"zip":102,"country":87,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Ajou University Hospital","Suwon","Gyeonggi-do","16499",{"type":44,"coordinates":104},[105,106],127.00889,37.29111,{"lat":106,"lon":105},[109,111],{"name":110,"role":32,"phone":10,"phoneExt":10,"email":10},"Jong Hwan Moon",{"name":110,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":113,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":124,"type":125},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.",[129],"Rib; Fracture",[131],"Non-flail chest","2024-03-05",{"date":134,"type":135},"2024-03-07","ACTUAL",{"date":137,"type":135},"2022-01-02",{"date":139,"type":125},"2026-12-30",{"name":5,"class":6},5]