[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527779":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":81,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Uppsala University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hip arthroplasty","EXPERIMENTAL","Operative treatment with hip arthroplasty i.e cemented total- or hemiarthroplasty.",[13],"Device: Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Internal fixation","ACTIVE_COMPARATOR","Operative treatment with internal fixation i.e screws, pins, hook pins, sliding hip device.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Treatment","Allocation to hip arthroplasty or internal fixation. The choice between hemi- or total hip arthroplasty in the arthroplasty group and type of osteosynthesis are the surgeon preference.",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"Olof Wolf, MD, PhD","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Sebastian Mukka, MD, PhD","CONTACT","+46730867111","+46","erika.olofsson@umu.se",{"name":38,"role":33,"phone":25,"phoneExt":25,"email":36},"Erika Olofsson, RN",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Olof Wolf","RECRUITING","Uppsala","Sweden","SE",{"type":47,"coordinates":48},"Point",[49,50],17.63889,59.85882,{"lat":50,"lon":49},[53],{"name":28,"role":33,"phone":25,"phoneExt":25,"email":54},"olof.wolf@surgsci.uu.se",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100527779","functional-outcome-after-orif-or-arthroplasty-for-femoral-neck-fracture-100527779",false,"NCT06152198","Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture","Internal Fixation Versus Hip Replacement in Older Adults with an Garden I\u002FII Femoral Neck Fracture: Physical Function and Pain in Elderly Patients - a Substudy of the Hipsther Trial","HipFunct","Inclusion Criteria:\n\n* Undisplaced (Garden I-II) femoral neck fracture (within 72h)\n* Treated at participating unit\n* Informed consent\n* Amenable for both treatment options\n* Included in the Hipsther trial\n\nExclusion Criteria:\n\n* No informed consent\n* Pathological or stress fracture\n* Peri-implant fracture\n* Previous inclusion of a contralateral Garden 1 or 2 femoral neck fracture","ALL","75 Years",{"count":68,"type":69},340,"ESTIMATED","INTERVENTIONAL",[72],"NA","Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients.\n\nMethods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) \\[21\\]. The aim is to recruit 340 patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty.\n\nThis substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level.\n\nInformation on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register.\n\nPrimary outcome The New Mobility Score will be used as the primary outcome with follow-up at 4- and 12 months.\n\nSecondary outcome WOMAC will be used as an additional hip specific patient reported outcome.\n\nActivities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL.\n\nPatients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE).\n\nThe Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms.\n\nThe Philadelphia Geriatric Center Morale Scale (PGCMS) and have been used in several studies including frail people living in residential care facilities and can be used among patients with cognitive impairment.",[75,76,77,78,79,80],"Hip Fractures","Femoral Neck Fractures","Undisplaced Fracture","Treatment Complication","Internal Fixation; Complications","Arthroplasty Complications",[82,83,84,85,86],"hip fracture","femoral neck fracture","treatment","hip arthroplasty","internal fixation","2024-11-28",{"date":89,"type":90},"2024-12-03","ACTUAL",{"date":92,"type":90},"2021-06-20",{"date":94,"type":69},"2027-09-01",{"name":5,"class":6},1]