[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VinUniversity\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100634474","evaluation-of-the-safety-feasibility-and-early-clinical-outcomes-of-patient-specific-bone-defect-implants-fabricated-from-titanium-alloy-ti-6al-4v-using-3d-printing-technology-100634474",false,"NCT07540156","Evaluation of the Safety, Feasibility, and Early Clinical Outcomes of Patient-Specific Bone Defect Implants Fabricated From Titanium Alloy (Ti-6Al-4V) Using 3D Printing Technology","Inclusion Criteria:\n\n* Diagnosed with a bone defect requiring surgical reconstruction, as determined by the treating orthopedic surgeon\n* Suitable candidate for implantation of a patient-specific device manufactured from Ti-6Al-4V\n* Able to undergo preoperative imaging (CT ± MRI) required for implant design\n* Willing and able to provide written informed consent\n* Willing to comply with scheduled follow-up visits and study assessments\n\nExclusion Criteria:\n\n* Active systemic or local infection at the surgical site at the time of implantation\n* Known hypersensitivity or allergy to titanium or titanium alloys\n* Severe uncontrolled comorbidities that significantly increase surgical risk (e.g., uncontrolled diabetes, severe cardiovascular disease)\n* Pregnant or breastfeeding women\n* Participation in another interventional clinical study that may interfere with the outcomes of this study\n* Inability to complete follow-up assessments within the required timeframe","ALL",{"count":17,"type":18},10,"ESTIMATED","INTERVENTIONAL",[21],"NA","The goal of this clinical trial is to evaluate the safety and feasibility of patient-specific bone defect implants fabricated from Ti-6Al-4V using 3D printing technology and to assess early clinical outcomes within the first 12 months following implantation of these customized devices. The main question it aims to answer is: \"In patients with bone defects requiring surgical reconstruction, are patient-specific bone defect implants fabricated from titanium alloy (Ti-6Al-4V) using 3D printing technology - designed and produced at VinUni, safe and feasible for clinical use, and do they result in favorable early clinical outcomes within the first 12 months following implantation?\"",[24,25],"Bone Loss","Bone Defects",[27,28,29,30],"Bone defect reconstruction","Patient-specific implants","Three-dimensional (3D) printing","Titanium alloy Ti-6Al-4V","NOT_YET_RECRUITING","2026-04-16",{"date":34,"type":35},"2026-04-20","ACTUAL",{"date":37,"type":18},"2026-04-01",{"date":39,"type":18},"2028-12-31",{"name":41,"class":42},"VinUniversity","OTHER",""]