[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583226":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":22,"responsibleParty":40,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Limacorporate S.p.a","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards.",null,"The study population for this clinical investigation includes subjects who suffered from a traumatic proximal femur fracture and underwent a Unipolar hemiarthroplasty with Cephalic femoral head from January 1st, 2023, onwards. Due to the characteristics of patients who underwent this type of surgery, it is expected that a considerable number of eligible patients would be in the elderly age.",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Monica Novello","CONTACT","+39 3358162087","monica.novello@enovis.com",{"name":19,"role":15,"phone":20,"phoneExt":10,"email":21},"Francesca Citossi","+39 0432 945511","clinicalresearch@enovis.com",[23],{"facility":24,"status":10,"city":25,"state":10,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"University Hospital J.A. Reimana","Prešov","5898","Slovakia","SK",{"type":30,"coordinates":31},"Point",[32,33],21.2355,48.99923,{"lat":33,"lon":32},[36],{"name":37,"role":15,"phone":38,"phoneExt":10,"email":39},"Dominik Kobak","051\u002F701 1899","kobakd@fnsppresov.sk",{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100583226","cephalic-femoral-heads-follow-up-100583226",false,"NCT06873568","Cephalic Femoral Heads Follow Up","A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture","Inclusion Criteria:\n\n* Displaced intracapsular hip fracture (Garden III-IV).\n* Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.\n* No concurrent joint disease at the time of the surgery.\n* Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.\n* Ability to ambulate independently with or without walking aids before surgery.\n* Subject willingness to participate.\n\nExclusion Criteria:\n\n* Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).\n* Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.\n* Pathological fracture secondary to malignant disease.\n* Subjects with rheumatoid arthritis or symptomatic osteoarthritis.\n* Previous treatment to the same hip for a fracture at the time of the surgery.\n* Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.\n* Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.\n* Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).","ALL","18 Years",{"count":52,"type":53},47,"ESTIMATED","OBSERVATIONAL","Study design: monocentric, retrospective, observational and post-market clinical study.\n\nPurpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.",[57,58],"Hip Arthroplasty Replacement","Femoral Fractures",[60,61],"femoral head","Partial hip arthroplasty","NOT_YET_RECRUITING","2025-03-13",{"date":65,"type":66},"2025-03-18","ACTUAL",{"date":68,"type":53},"2025-10",{"date":70,"type":53},"2027-12",{"name":5,"class":6},1]