[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoral-shaft-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoral-shaft-fractures":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Femoral Shaft Fractures","Femur Fractures","Femur Fracture","RECRUITING","2026-07-28",{"date":33,"type":34},"2026-07-31","ACTUAL",{"date":36,"type":34},"2026-07-01",{"date":38,"type":21},"2028-12-29",{"name":40,"class":41},"Beijing Jishuitan Hospital","OTHER"]