[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634474":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":20,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"VinUniversity","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient-specific 3D-printed Ti-6Al-4V implant reconstruction","EXPERIMENTAL","Participants in this arm will undergo surgical reconstruction of bone defects using patient-specific implants fabricated from titanium alloy (Ti-6Al-4V) through three-dimensional (3D) printing technology. Implants are designed based on preoperative imaging data (CT ± MRI) and manufactured using laser powder bed fusion\u002Fselective laser melting. The study evaluates the safety, feasibility, and early clinical outcomes of these customized implants during a 12-month follow-up period.",[13],"Device: Patient-specific 3D-printed Ti-6Al-4V bone implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Patient-specific 3D-printed Ti-6Al-4V bone implant","The investigational device is a patient-specific bone implant manufactured from titanium alloy Ti-6Al-4V using metal additive manufacturing technology. The implant is designed individually for each patient based on medical imaging data (CT or MRI), which are converted from DICOM format into three-dimensional digital models for anatomical reconstruction and implant design. The device is fabricated using selective laser melting (SLM) technology, in which high-power laser beams selectively fuse layers of Ti-6Al-4V powder to produce the final implant geometry. The manufacturing process is performed on a metal additive manufacturing system under an inert gas environment to prevent oxidation and ensure material integrity. Titanium powder feedstock complies with ASTM F2924 specifications for medical-grade Ti-6Al-4V used in powder bed fusion processes. Following printing, implants undergo standardized post-processing procedures including support removal, surface cleaning and finishing, stress-",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Trung Dzung Tran, Professor, PhD, MD","CONTACT","+84983762005","dung.tt@vinuni.edu.vn",[28],{"facility":29,"status":20,"city":30,"state":20,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"3D Technology in Medicine Center (3D Lab, VinUni)","Hanoi","100000","Vietnam","VN",{"type":35,"coordinates":36},"Point",[37,38],105.84117,21.0245,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":20,"phoneExt":20,"email":26},"Trung Dung Tran, Professor, PhD, MD",{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[46],{"name":47,"class":6},"Vinmec Healthcare System","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":56,"type":57},10,"ESTIMATED","INTERVENTIONAL",[60],"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?\"",[63,64],"Bone Loss","Bone Defects",[66,67,68,69],"Bone defect reconstruction","Patient-specific implants","Three-dimensional (3D) printing","Titanium alloy Ti-6Al-4V","NOT_YET_RECRUITING","2026-04-16",{"date":73,"type":74},"2026-04-20","ACTUAL",{"date":76,"type":57},"2026-04-01",{"date":78,"type":57},"2028-12-31",{"name":5,"class":6},1]