[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429227":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"three-screw group","ACTIVE_COMPARATOR","three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck",[13],"Device: three cancellous screws",{"label":15,"type":16,"description":17,"interventionNames":18},"four-screw group","EXPERIMENTAL","the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.",[19],"Device: four cancellous screws",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","three cancellous screws","All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Three screws for internal fixation in the three-screw group, and three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"four cancellous screws","All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Four screws for internal fixation in the four-screw group, and the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.",[15],[32],{"name":33,"affiliation":5,"role":34},"Fang Zhou, M.D.","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"XiangYu Xu, M.D.","CONTACT","+86-15210849431","307542744@qq.com",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Yang Lv, M.D.","lvyang42@126.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Beijing","Beijing Municipality","100191","China","CN",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59,61],{"name":42,"role":38,"phone":60,"phoneExt":26,"email":43},"+8610-82267010",{"name":62,"role":38,"phone":39,"phoneExt":26,"email":40},"Xiangyu Xu, M.D.",{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100429227","three-cancellous-screws-versus-four-cancellous-screws-for-femoral-neck-fixation-100429227",false,"NCT04869332","Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation","A Prospective Randomised Controlled Clinical Trial: Three Cancellous Screws Versus Four Cancellous Screws for Fixation of Femoral Neck Fractures","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with unilateral femoral neck fractures that will be treated with internal fixation\n* According to AO fracture classification, subjects with the fracture type (31-B)\n* Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.\n* Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.\n* The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and follow-up visits and can cooperate with the research procedures.\n* In-label use of the MCS.\n\nExclusion Criteria:\n\n* Subject does not provide voluntary consent to participate in the study.\n* The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)\n* The subjects were pregnant or lactating women.\n* The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.\n* Garden classification III and IV of femoral neck fracture patients older than 65 years\n* Concurrent hip osteoarthritis.\n* Fractures where the operative treatment will occur more than three weeks after the primary injury\n* Patients combined with femoral head fractures(31-C), femoral shaft fractures(32-A\u002FB\u002FC) or femoral trochanteric area fracture (31-A1\u002FA2\u002FA3).\n* Pathological fracture (e.g., primary or metastatic tumor)\n* Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome\n* Multiple systemic injuries judged by researchers not suitable for enrollment.\n* Revision surgeries (for example, due to malunion, nonunion or infection)\n* Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc\n* Patients with anaesthetic and surgical contraindications\n* Patients known to be allergic to implant components\n* Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)\n* Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);\n* Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers.\n* Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).","ALL","18 Years",{"count":75,"type":76},290,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study is a prospective randomized controlled clinical study. Patients with femoral neck fracture (AO classification 31-B) will be randomly divided into three-screw fixation group and four-screw fixation group. The internal fixation failure rate (IFFR) and functional outcomes of the two groups will be compared and the patients will be followed up to 2 years after surgery.",[82,83],"Femoral Neck Fractures","Internal Fixation",[85,86,87],"femoral neck fractures","multiple cancellous screws","RCT","2021-04-30",{"date":90,"type":91},"2021-05-03","ACTUAL",{"date":93,"type":91},"2021-04-08",{"date":95,"type":76},"2026-12-31",{"name":5,"class":6},1]