[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distal-tibial-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distal-tibial-fracture":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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Distal Tibial Fracture","Tibial Fractures","RECRUITING","2026-07-28",{"date":32,"type":33},"2026-07-29","ACTUAL",{"date":35,"type":33},"2026-07-01",{"date":37,"type":21},"2028-12-31",{"name":39,"class":40},"Beijing Jishuitan Hospital","OTHER",2]