[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548101":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":84,"collaborators":87,"id":89,"slug":26,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":26,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-surgical treatment","EXPERIMENTAL","Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit,",[13],"Procedure: Non surgical",{"label":15,"type":16,"description":17,"interventionNames":18},"Procedure: Surgical treatment","ACTIVE_COMPARATOR","The surgical group will receive osteosynthesis with a locking plate or an intramedullary locking nail, according to the surgeon's choice",[19],"Procedure: Surgical",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Surgical","Surgical group: After osteosynthesis, they will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. They will be referred to post-operative rehabilitation in the municipalities. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non surgical","Non-surgical group: Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit, 10-14 days post-injury. Patients will be referred to rehabilitation in the municipalities. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments.",[9],[32],{"name":33,"affiliation":34,"role":35},"Line Løjbert Houkjær, M.D.","Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Line Løjbert Houkjær, M.D., ph.d.-student","CONTACT","61711681","lihol@regionsjaelland.dk",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Stig Brorson, Prof.","sbror@regionsjaelland.dk",[46,68],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Centre for Evidence-Based Orthopaedics, Zealand University Hospital","RECRUITING","Køge","Region Sjælland","4600","Denmark",{"type":54,"coordinates":55},"Point",[56,57],12.18214,55.45802,{"lat":57,"lon":56},[60,61,63,66],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":62,"role":39,"phone":26,"phoneExt":26,"email":44},"Stig Brorson",{"name":64,"role":65,"phone":26,"phoneExt":26,"email":26},"Zaid Issa, M.D.","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":26,"phoneExt":26,"email":26},"Kenneth B Holtz, M.D.",{"facility":69,"status":70,"city":71,"state":26,"zip":72,"country":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Tampere University Hospital","NOT_YET_RECRUITING","Tampere","33520","Finland",{"type":54,"coordinates":75},[76,77],23.78712,61.49911,{"lat":77,"lon":76},[80,82],{"name":81,"role":39,"phone":26,"phoneExt":26,"email":26},"Antti P Launonen, M.D.",{"name":83,"role":65,"phone":26,"phoneExt":26,"email":26},"Bakir O. Sumrein, M.D.",{"type":35,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Line Lojbert Houkjaer","Principal Investigator, M.D.",[88],{"name":69,"class":6},"100548101",false,"NCT06416618","Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years","Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial","PHF50-65","Inclusion Criteria:\n\n* Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility.\n* Patients should be cognitively capable of answering the follow-up questionnaires.\n\nExclusion Criteria:\n\n* The patient does not understand written and spoken native language (Danish or Finnish\u002FSwedish)\n* Inability to give informed consent\n* Fractures assessed to be unreconstructedly by the treating surgeon\n* Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface\n* Less than 25% contact between head fragment and metaphysis\u002Fdiaphysis measured at two perpendicular radiographs at two weeks.\n* Pathological fractures or previous fractures in the same proximal humerus\n* Concomitant fractures, which could influence the outcome\n* Paralysis in upper extremity","ALL","50 Years","65 Years",{"count":100,"type":101},60,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture.\n\nThe main questions it aims to answer are:\n\n• Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up?\n\nAim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale.\n\nThe study compare operation with either plate or nail fixation to non-surgical treatment.\n\nParticipants will:\n\n* Receive either surgical treatment or non-surgical treatment.\n* At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L).\n\nThe primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.",[107,108],"Proximal Humeral Fracture","Shoulder Fractures","2025-09-11",{"date":111,"type":112},"2025-09-18","ACTUAL",{"date":114,"type":112},"2024-05-15",{"date":116,"type":101},"2028-12-31",{"name":5,"class":6},2]