[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649883":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Beijing Jishuitan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-Assisted Closed Reduction","EXPERIMENTAL","Participants will undergo robot-assisted closed reduction followed by conventional proximal femoral intramedullary nailing internal fixation, using the Robot-Assisted Fracture Reduction (RAFR) system. The robotic system will identify bone fragment displacement parameters based on pre-operative 3D CT images, plan the optimal reduction pathway, and execute or assist the surgeon in performing the closed reduction under real-time navigation and safety control. After reduction, a standard proximal femoral intramedullary nail will be implanted using routine minimally invasive surgical techniques to achieve stable internal fixation.",[13],"Procedure: Robot-assisted closed reduction and internal fixation",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Manual Closed Reduction","ACTIVE_COMPARATOR","Patients assigned to this arm will undergo traditional manual closed reduction of the intertrochanteric femoral fracture . The reduction will be executed by the surgeon using conventional traction and manual manipulation under standard fluoroscopic guidance. Following manual closed reduction, conventional proximal femoral intramedullary nailing internal fixation will be performed by the surgeon.",[19],"Procedure: Conventional manual closed reduction and internal fixation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Robot-assisted closed reduction and internal fixation","The key distinguishing feature of this intervention is the transition from empirical, experience-based traction to computer-planned, quantitatively-controlled reduction. The robotic system creates an individualized 3D model based on pre-operative thin-layer CT and automatically calculates precise fragment displacement parameters. Unlike manual methods, the reduction pathway is executed or guided via real-time spatial navigation and digital monitoring with strict safety interlocking mechanisms. This approach aims to reduce human judgment bias and enhance 3D anatomical alignment precision, particularly in correcting complex translation and rotational deformities.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional manual closed reduction and internal fixation","This intervention relies entirely on the surgical team's clinical experience, using a standard orthopedic traction table or manual manipulation to achieve bone alignment. Unlike the experimental group, no intelligent robotic systems, 2D-3D registration software, or spatial tracking devices are permitted during any stage of the operation. Reduction quality is evaluated intraoperatively using routine two-dimensional C-arm fluoroscopy (AP and lateral views) rather than computerized 3D planning. If closed alignment is inadequate, the surgeon may convert to a limited open reduction using joysticks or clamps based on empirical judgment.",[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":53},"2987566589@qq.com",{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57,59],{"name":58,"class":6},"Beihang University",{"name":60,"class":6},"Aerospace Center Hospital","100649883","robot-assisted-closed-reduction-and-internal-fixation-for-intertrochanteric-femoral-fractures-100649883",false,"NCT07738458","Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures","Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures: A Randomized Controlled Trial","Inclusion Criteria：\n\n* Age 18 to 80 years, inclusive.\n* Male or female participants.\n* Acute, closed intertrochanteric femoral fracture.\n* AO\u002FOTA classification 31-A intertrochanteric femoral fracture.\n* Fracture requiring closed reduction and proximal femoral intramedullary nailing.\n* Injury-to-surgery interval no more than 14 days.\n* Participant or legally authorized representative is fully informed about the study.\n* Written informed consent voluntarily provided by the participant or legally authorized representative.\n\nExclusion Criteria：\n\n* Open fracture.\n* Pathological fracture.\n* Old fracture with an injury-to-surgery interval greater than 14 days.\n* Multiple fractures.\n* Previous surgery involving the affected hip joint.\n* Deformity of the affected hip joint.\n* Severe osteoarthritis of the affected hip joint.\n* Significant neuromuscular disease affecting lower limb function.\n* Significant neuromuscular disease affecting postoperative rehabilitation.\n* Severe systemic comorbidity that makes the participant unable to tolerate anesthesia or surgery.\n* Severe organ dysfunction that makes the participant unable to tolerate anesthesia or surgery.\n* Pregnancy.\n* Lactation.\n* Cognitive impairment that prevents compliance with postoperative follow-up or rehabilitation protocols.\n* Active psychiatric illness that prevents compliance with postoperative follow-up or rehabilitation protocols.\n* Other condition that prevents compliance with postoperative follow-up or rehabilitation protocols.\n* Current participation in another clinical trial that may interfere with evaluation of this study's outcomes.","ALL","18 Years","80 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen\u002FOrthopaedic Trauma Association \\[AO\u002FOTA\\] classification 31-A). The main question it aims to answer is:\n\nWhether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard.\n\nResearchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic system significantly improves 3D anatomical reduction precision, reduces intraoperative fluoroscopy times and radiation doses, shortens operation times, and ultimately enhances long-term clinical hip functions and health-related quality of life.\n\nParticipants will be asked to do the following tasks:\n\nComplete baseline medical screening, standard hip X-rays, and bilateral full-length thin-layer CT scans before the surgery.\n\nUndergo a 1:1 randomized allocation after anesthesia to receive either robot-assisted autonomous closed reduction or traditional experience-based manual closed reduction, both followed by conventional proximal femoral intramedullary nailing internal fixation.\n\nReceive post-operative low-dose CT scans before discharge or within 2 weeks after surgery to evaluate the fracture reduction quality.\n\nFollow a standardized Enhanced Recovery After Surgery (ERAS) rehabilitation pathway and attend scheduled follow-up visits at 1, 3, and 6 months after the surgery to monitor bone healing, hip functions, and quality of life",[79,80,81],"Intertrochanteric Fractures","Intertrochanteric Fractures of the Hip","Intertrochanteric Fractures of the Femur","2026-07-28",{"date":84,"type":85},"2026-07-31","ACTUAL",{"date":87,"type":85},"2026-07-01",{"date":89,"type":73},"2028-12-29",{"name":5,"class":6},1]