[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649807":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":55,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Beijing Jishuitan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-Assisted Close Reduction","EXPERIMENTAL","Patients in this arm will undergo autonomous closed reduction of the fracture assisted by a robotic system, followed by internal fixation performed by the surgeon.",[13],"Procedure: Robot-Assisted Closed Reduction",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Close Reduction","ACTIVE_COMPARATOR","Patients in this arm will undergo traditional closed reduction (or open reduction if necessary) performed manually by the surgeon, followed by conventional internal fixation.",[19],"Procedure: Conventional Closed Reduction",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Robot-Assisted Closed Reduction","Patients in this group will undergo robotic-assisted closed reduction of the femoral shaft fracture. The procedure utilizes a robotic system for intraoperative navigation and automated reduction planning based on preoperative computed tomography (CT) imaging. The robotic system assists the surgeon in achieving precise fracture alignment. Following successful reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Closed Reduction","Patients in this group will undergo traditional manual closed reduction of the femoral shaft fracture. The reduction will be performed by the surgeon using standardized traction and manipulation techniques under real-time fluoroscopic guidance. Following manual reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Chunpeng Zhao","CONTACT","+86 18610012704","zcpllza2008@163.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Beijing","Beijing Municipality","100035","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[56,58],{"name":57,"class":6},"Beihang University",{"name":59,"class":6},"Aerospace Center Hospital","100649807","robot-assisted-closed-reduction-and-internal-fixation-for-femoral-shaft-fractures-100649807",false,"NCT07738380","Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures","Robot-Assisted Versus Traditional Closed Reduction and Internal Fixation for Femoral Shaft Fractures: A Randomized Controlled Trial","Inclusion Criteria：\n\n* Age 18 to 80 years, inclusive.\n* Unilateral, acute, closed femoral shaft fracture.\n* AO\u002FOTA classification 32-A, 32-B, or 32-C femoral shaft fracture.\n* Time from injury to surgery no more than 21 days.\n* Ability to walk independently before injury, with or without assistive devices.\n* Ability to provide written informed consent.\n\nExclusion Criteria：\n\n* Open fracture.\n* Multiple severe trauma requiring immediate priority management.\n* Asymmetry of the lower limbs.\n* History of ipsilateral femoral shaft malunion.\n* History of ipsilateral femoral deformity that significantly affects assessment of - limb rotation or length.\n* Ipsilateral fracture at another site.\n* Pathological fracture caused by tumor, metabolic bone disease, or other underlying bone pathology.\n* Complex hardware from previous ipsilateral surgery.\n* History of ipsilateral surgery that significantly affects clinical or radiographic evaluation.\n* Active infection.\n* Severe underlying medical condition that makes the patient unable to tolerate surgery.\n* Cognitive impairment that prevents study participation or follow-up.\n* Poor compliance with study procedures or follow-up.\n* Pregnancy or lactation.\n* Judged by the investigators to be unsuitable for enrollment.\n* Unable to complete the planned follow-up period.\n* Refusal to undergo randomization.\n* Refusal to participate in the clinical study.","ALL","18 Years","80 Years",{"count":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial is to evaluate the safety and efficacy of robot-assisted closed reduction for patients with femoral shaft fractures. The main questions it aims to answer are:\n\nDoes robot-assisted closed reduction provide a statistically significant improvement in the excellent and good reduction rates compared to conventional surgeon-performed reduction? How do the two reduction methods compare in terms of surgical efficiency, fracture healing, and patient functional outcomes? Researchers will compare the robot-assisted closed reduction group to the conventional surgeon-performed reduction group to see if robot-assisted surgery improves the precision of fracture reduction, stability of alignment, and post-operative functional recovery while minimizing trauma.\n\nParticipants will:\n\nUndergo standardized screening to ensure they meet the inclusion criteria for acute, unilateral, closed femoral shaft fractures (Arbeitsgemeinschaft für Osteosynthesefragen\u002FOrthopaedic Trauma Association \\[AO\u002FOTA\\] classification 32).\n\nBe randomized in a 1:1 ratio to receive either robot-assisted closed reduction or traditional surgeon-performed closed reduction, both followed by internal fixation.\n\nComplete standardized perioperative management and follow-up assessments at 1, 3, 6, and 12 months post-surgery, including functional scales such as the Lower Extremity Functional Scale (LEFS) and the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L), as well as radiographic imaging to monitor bone healing and potential complications.",[78,79,80],"Femoral Shaft Fractures","Femur Fractures","Femur Fracture","2026-07-28",{"date":83,"type":84},"2026-07-31","ACTUAL",{"date":86,"type":84},"2026-07-01",{"date":88,"type":72},"2028-12-29",{"name":5,"class":6},1]