[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649478":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":30,"locations":36,"responsibleParty":60,"collaborators":62,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Beijing Jishuitan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-Assisted Group","EXPERIMENTAL",null,[13],"Device: Robot-assisted closed reduction",{"label":15,"type":16,"description":11,"interventionNames":17},"Traditional Group","ACTIVE_COMPARATOR",[18],"Procedure: Traditional surgeon-led reduction",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Robot-assisted closed reduction","The patient undergoes automated or human-robot collaborative closed fracture reduction powered by an intelligent robotic system. The system integrates deep-learning-based bone segmentation, automatic reduction planning, and a self-adaptive 2D-3D image registration framework to achieve sub-millimeter positioning feedback and force-position collaborative security gates. Following successful reduction, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"PROCEDURE","Traditional surgeon-led reduction","The patient undergoes conventional closed or open fracture reduction performed entirely by the surgical team based on traditional clinical experience under ordinary C-arm fluoroscopic guidance. Internal fixation is achieved using standard distal tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Chunpeng Zhao, MD \u002F Chief Physician","CONTACT","+86 18610012704","zcpllza2008@163.com",[37,54],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Aerospace Center Hospital","RECRUITING","Beijing","Beijing Municipality","100035","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":11,"phoneExt":11,"email":11},"Yonghui Liang, MD \u002F Chief Physician",{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},{"type":46,"coordinates":56},[48,49],{"lat":49,"lon":48},[59],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[63],{"name":38,"class":6},"100649478","robot-assisted-closed-reduction-and-internal-fixation-for-extra-articular-distal-tibial-fractures-100649478",false,"NCT07733271","Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures","Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)","Inclusion Criteria:\n\n* Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen\u002FOrthopaedic Trauma Association AO\u002FOTA 43-A)\n* Time from injury to surgery \\\u003C 21 days\n* Able to walk independently before injury (assistive devices allowed)\n\nExclusion Criteria:\n\n* Open fractures or multiple severe traumas requiring priority treatment\n* Asymmetrical lower extremities, or prior malunion of the ipsilateral tibia, or pre-existing deformities significantly affecting rotation\u002Flength evaluation\n* Ipsilateral fractures combined with other sites\n* Pathological fractures (tumor\u002Fmetabolic)\n* Prior complex implants in place or previous surgeries significantly affecting evaluation\n* Active infection or severe systemic medical contraindications (unable to tolerate anesthesia\u002Fsurgery)\n* Cognitive impairment, poor compliance, pregnancy, or lactation\n* Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury)\n* Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization\u002Fenrollment","ALL","18 Years","80 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study aims to evaluate the clinical efficacy and safety of an intelligent fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure. This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method. The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.",[82,83],"Distal Tibial Fracture","Tibial Fractures","2026-07-28",{"date":86,"type":87},"2026-07-29","ACTUAL",{"date":89,"type":87},"2026-07-01",{"date":91,"type":76},"2028-12-31",{"name":5,"class":6},2]